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COMPLETEDPHASE4

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

NCT05857267•Laboratorios Poen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Older than 18 years old
•Patients with POAG and OH
•PIO \< 20 mmHg
•Under treatment with Dorzolamide + Timolol BAK preserved at least 6 month after
•OSDI \> 13 \& one of these ocular signs (BUT \<6sec or Schirmer test \< 5 mm/5min or corneal staining positive)
•Corneal thickness between 520-580 um.

Exclusion Criteria

•Patient with severe respiratory diseases (asthma, COPD and other bronchospactic diseases).
•Patient with cardiovascular diseases (Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock).
•Severe renal impairment (CrCl \<30 mL/min)
•Progressive diseases of the retina other than glaucoma
•Inflammation and/or infecctions active
•Ocular surface syndrome other than Ocular Surface disease
•Eyelid disorder
•Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors
•Patient that requires another antigluacomatous eye drop other than fixed combination of Dorzolamide/Timolol
•Patients who use regularly lubricant eye drops
+8 more criteria

Locations (6)

Clínica de Ojos Dr. Nano

Olivos, Buenos Aires, Argentina

Consultorio Dr. Peyret

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Gonella Oftalmólogos

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Centro Diagnóstico Dr. Gentile

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Centro oftalmológico Dr. Casiraghi & asociados

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., Argentina

Consultorios de Oftalmología

Buenos Aires, Argentina

Key Dates

Start Date

March 7, 2023

Primary Completion Date

November 4, 2024

Completion Date

November 4, 2024

Last Updated

November 6, 2024

Enrollment

ACTUAL participants

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Dorzolamide / Timolol Ophthalmic Solution

DRUG

dorzolamide/timolol

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

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RECRUITINGNA

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

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Primary Open Angle GlaucomaOcular Hypertension+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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