Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-01 @ 7:18 PM
Study NCT ID:
NCT02643004
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2015-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
Sponsor:
Organization:
Raw JSON
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Scale 0-4, 0.25 steps, 0=normal, 4=severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.'}, {'type': 'PRIMARY', 'title': 'Overall Subjective Score of Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.3', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '80.0', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.'}, {'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.8', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '90.5', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.0', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '82.1', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.'}, {'type': 'PRIMARY', 'title': 'Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '82.3', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.'}, {'type': 'PRIMARY', 'title': 'Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '91.9', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '88.4', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Horizontal Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Extremely nasal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Slightly temporal', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Extremely temporal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Horizontal Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Extremely nasal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly temporal', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Extremely temporal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Week', 'description': 'Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Vertical Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Extremely nasal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000'}, {'value': '65.7', 'groupId': 'OG001'}]}]}, {'title': 'Slightly temporal', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Extremely temporal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vertical Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Extremely nasal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly temporal', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Extremely temporal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Week', 'description': 'Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Lens Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Extremely inadequate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inadequate', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Slightly excessive', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Extremely excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Extremely inadequate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inadequate', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Slightly excessive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Extremely excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Week', 'description': 'Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Baseline: High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Low Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': '1 week: High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': '1 week: Low Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol deviations occurred and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Lens Surface - Deposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Surface - Deposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000'}, {'value': '99.0', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Lens Surface - Debris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '82.9', 'groupId': 'OG000'}, {'value': '93.0', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Surface - Debris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}, {'value': '96.0', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.'}, {'type': 'SECONDARY', 'title': 'Lens Surface - Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Surface - Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens'}, {'id': 'OG001', 'title': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon A, Then Stenfilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens\n\nStenfilcon A: contact lens'}, {'id': 'FG001', 'title': 'Stenfilcon A, Then Senofilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.\n\nStenfilcon A: contact lens\n\nSenofilcon A: contact lens'}], 'periods': [{'title': 'First Intervention (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Baseline Characteristics', 'description': 'Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.\n\nSenofilcon A: contact lens\n\nStenfilcon A: contact lens'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2015-12-28', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2015-12-28', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-13', 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Physiology', 'timeFrame': 'Baseline and 1 week', 'description': 'Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.'}, {'measure': 'Overall Subjective Score of Lenses', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.'}, {'measure': 'Comfort', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.'}, {'measure': 'Dryness', 'timeFrame': '1 week', 'description': 'Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.'}, {'measure': 'Vision', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.'}], 'secondaryOutcomes': [{'measure': 'Horizontal Centration', 'timeFrame': 'Baseline', 'description': 'Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal'}, {'measure': 'Horizontal Centration', 'timeFrame': '1 Week', 'description': 'Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal'}, {'measure': 'Vertical Centration', 'timeFrame': 'Baseline', 'description': 'Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal'}, {'measure': 'Vertical Centration', 'timeFrame': '1 Week', 'description': 'Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal'}, {'measure': 'Lens Movement', 'timeFrame': 'Baseline', 'description': 'Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.'}, {'measure': 'Lens Movement', 'timeFrame': '1 Week', 'description': 'Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.'}, {'measure': 'Visual Acuity', 'timeFrame': 'Baseline and 1 week', 'description': 'Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.'}, {'measure': 'Lens Surface - Deposition', 'timeFrame': 'Baseline', 'description': 'Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe'}, {'measure': 'Lens Surface - Deposition', 'timeFrame': '1 week', 'description': 'Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe'}, {'measure': 'Lens Surface - Debris', 'timeFrame': 'Baseline', 'description': 'Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe'}, {'measure': 'Lens Surface - Debris', 'timeFrame': '1 week', 'description': 'Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe'}, {'measure': 'Lens Surface - Wettability', 'timeFrame': 'Baseline', 'description': 'Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe'}, {'measure': 'Lens Surface - Wettability', 'timeFrame': '1 week', 'description': 'Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.', 'detailedDescription': 'The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\nSubjects will only be eligible for the study if:\n\n* They are of legal age (18) and capacity to volunteer.\n* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.\n* They are willing and able to follow the protocol.\n* They agree not to participate in other clinical research for the duration of this study.\n* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)\n* They have a spectacle cylindrical correction of -0.75D or less in each eye.\n* At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.\n* They currently use soft contact lenses or have done so in the previous six months.\n* They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).\n\nExclusion criteria\n\nSubjects will not be eligible to take part in the study if:\n\n* They have an ocular disorder which would normally contra-indicate contact lens wear.\n* They have a systemic disorder which would normally contra-indicate contact lens wear.\n* They are using any topical medication such as eye drops or ointment.\n* They have had cataract surgery.\n* They have had corneal refractive surgery.\n* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.\n* They are pregnant or lactating.\n* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.\n* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.\n* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.\n* They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.'}, 'identificationModule': {'nctId': 'NCT02643004', 'briefTitle': 'The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Senofilcon A', 'description': 'Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.', 'interventionNames': ['Device: Senofilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stenfilcon A', 'description': 'Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.', 'interventionNames': ['Device: Stenfilcon A']}], 'interventions': [{'name': 'Senofilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['Senofilcon A']}, {'name': 'Stenfilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['Stenfilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9PL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Eurolens Research - The University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Carole Maldonado-Codinal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurolens Research, University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}