NCT05857267

Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety

Phase IV, Multicenter, Double-blind, Randomized, Controlled, Parallel-group, Trial to Evaluate the Efficacy and Safety of Dozolamide 2%/Timolol 0,5% PF vs Dorzolamide 2%/Timolol 0,5% BAK-preserved in OAG or OH

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Laboratorios Poen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Dorzolamide / Timolol Ophthalmic Solution	Dorzolamide-timolol fixed combination in a preservative-free multidose device
DRUG	dorzolamide/timolol	Dorzolamide-timolol BAK-preserved fixed combination

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2023-05-12
• Last updated: 2024-11-06

Locations

6 sites across 1 country: Argentina