Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-20 @ 2:47 AM
Study NCT ID:
NCT06686368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-13
First Post:
2024-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'All products will have their label removed and placed a white sticker showing the group (A or B or C). Products with be put in a white box with the letter indicated on it.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'in vivo, human patient with confirmed Evaporative dry eye disease'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluorescein Tear Break-Up Time (FTBUT) in seconds', 'timeFrame': 'Day 1 - 30 minutes post installation', 'description': 'The primary outcome of the study is FBUT at 30 minutes post-installation'}], 'secondaryOutcomes': [{'measure': 'Fluorescein Tear Break-Up Time (FTBUT) in seconds', 'timeFrame': 'Day 7 - day 28', 'description': 'One of the secondary endpoints is FTBUT at day 7 and day 28'}, {'measure': 'Tear Meniscus Height (TMH) in milimiters', 'timeFrame': 'Day 1 - Day 7 - day 28', 'description': 'One of the secondary endpoints is TMH at day 1 (30 minutes post-installation), 7 and day 28'}, {'measure': 'Osmolarity in mOsm/L', 'timeFrame': 'Day 1 - Day 7 - day 28', 'description': 'One of the secondary endpoints is osmolarity at day 1 (30 minutes post-installation), 7 and day 28'}, {'measure': 'Number of Corneal and Conjunctival spots', 'timeFrame': 'Day 7 - day 28', 'description': 'One of the secondary endpoints is Corneal and conjunctival spots at day 7 and day 28'}, {'measure': 'Ocular Surface and Disease Index (OSDI) score', 'timeFrame': 'Day 7 - day 28', 'description': 'One of the secondary endpoints is OSDI score at day 7 and day 28'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye Disease', 'Lubricant eye drops', 'Meibomian Gland Dysfunction', 'Evaporative dry eye'], 'conditions': ['Evaporative Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye', 'detailedDescription': 'Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is at least 18 years of age and has full legal capacity to volunteer.\n* Has read and signed an information consent form.\n* Is willing and able to follow instructions and maintain the appointment schedule.\n* Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:\n\n * OSDI ≥ 13\n * And TBUT \\< 10 seconds\n * And \\>5 spots of corneal fluorescein staining OR \\> 9 conjunctival spots\n * Meibomian Gland score of 1 or higher using NEI grading criteria.\n\nExclusion Criteria:\n\n* Is participating in any concurrent clinical or research study.\n* Is wears contact lenses.\n* Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.\n* Has undergone eye surgery involving the cornea or conjunctiva.\n* Aqueous deficient DED patients.\n* Is currently or has used any of the study drops in the last 3 months.\n* Has any known allergy or intolerance to any of the study drops.\n* Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable\n* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease).\n* Has known sensitivity to sodium fluorescein.\n* Is pregnant, lactating or planning a pregnancy at the time of enrolment?\n* Unwilling to stop using their habitual artificial tears for the study.\n* Has been fitted with punctal plugs within 30 days before the study screening visit.\n* Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.'}, 'identificationModule': {'nctId': 'NCT06686368', 'briefTitle': 'Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'I-MED Pharma'}, 'officialTitle': 'Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CR001-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I-DROP MGD', 'description': 'High Molecular weight hyaluronic acid + PC containing lubricant eye drop Receiving lubricant eye drops with high molecular weight hyaluronic acid', 'interventionNames': ['Device: I-DROP MGD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thealoz Duo', 'description': 'Low Molecular weight hyaluronic acid + Trehalose containing lubricant eye dropReceiving lubricant eye drops with low molecular weight hyaluronic acid', 'interventionNames': ['Device: Theloze Duo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Systane Complet PF', 'description': 'No hyaluronic acid containing lubricant eye drop Receiving lubricant eye drops without hyaluronic acid', 'interventionNames': ['Device: Systane Complete PF']}], 'interventions': [{'name': 'I-DROP MGD', 'type': 'DEVICE', 'description': 'All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30', 'armGroupLabels': ['I-DROP MGD']}, {'name': 'Theloze Duo', 'type': 'DEVICE', 'description': 'All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30', 'armGroupLabels': ['Thealoz Duo']}, {'name': 'Systane Complete PF', 'type': 'DEVICE', 'description': 'All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30', 'armGroupLabels': ['Systane Complet PF']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karim Fahmy, Ph.D.', 'role': 'CONTACT', 'email': 'kfahmy@imedpharma.com', 'phone': '1-800-463-1008'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I-MED Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}