Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-24 @ 2:46 PM
Study NCT ID:
NCT00469157
Status:
COMPLETED
Last Update Posted:
2008-04-17
First Post:
2007-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refractive Surgery and Optive Compatibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-16', 'studyFirstSubmitDate': '2007-05-02', 'studyFirstSubmitQcDate': '2007-05-03', 'lastUpdatePostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess compatibility', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'comfort', 'timeFrame': '8 months'}]}, 'conditionsModule': {'keywords': ['compatibility of Optive after PRK or LASIK'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women 18 and over\n* Patients undergoing refractive surgery\n\nExclusion Criteria:\n\n* Concurrent ocular conditions or pathology that could affect patient's ability to complete study\n* Concurrent use of topical medications other than study medications\n* Use of systemic medications with ocular drying sequelae:\n\n * Antihistamines\n * Decongestants\n * Antispasmotics\n * Antidepressants"}, 'identificationModule': {'nctId': 'NCT00469157', 'briefTitle': 'Refractive Surgery and Optive Compatibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'Refractive Surgery and Optive Compatibility Study', 'orgStudyIdInfo': {'id': '5303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1.', 'interventionNames': ['Drug: Optive']}], 'interventions': [{'name': 'Optive', 'type': 'DRUG', 'description': 'Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery', 'armGroupLabels': ['1.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'TLC', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}], 'overallOfficials': [{'name': 'Loren Rude, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Loren Rude, OD', 'oldOrganization': 'TLC'}}}}