Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bim(Atoprost) qd or Lat QD With Dor-tim BID

CTGlaucoma1

IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed.

2024-04-01

2024-07-01

2024-07-01

Recruiting

Early phase I

60

Inclusion Criteria: * Adult glaucoma patients who are taking drops: dor-tim and Latanoprost Ophthalmic Solution 0.005% (Lat) and come in for an appointment during the trial period Exclusion Criteria: * Patients who had an SLT or glaucoma procedure or surgery within 3 months of enrollment will be excluded. Other exclusion criteria include the logistical inability to follow up with the trial, the inability to relax eye muscles for an accurate tonometry measurement, and the inability to instill medications. The final determination to be included in the study will be made by the Physician on the day of the appointment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.\n\nAt each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-04-17