Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety
NCT05857267 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2024-11-06
Summary
The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.
Conditions
- Glaucoma, Open-Angle
- Ocular Hypertension
Interventions
- DRUG
-
Dorzolamide / Timolol Ophthalmic Solution
Dorzolamide-timolol fixed combination in a preservative-free multidose device
- DRUG
-
dorzolamide/timolol
Dorzolamide-timolol BAK-preserved fixed combination
Sponsors & Collaborators
-
Laboratorios Poen
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-07
- Primary Completion
- 2024-11-04
- Completion
- 2024-11-04
Countries
- Argentina
Study Locations
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