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Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL

NCT05973318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-08-02

No results posted yet for this study

Summary

The goal of this study is to compare efficacy and safety of Dorzotimol eye drops, 20 mg/mL + 5 mg/mL manufactured by JADRAN-GALENSKI LABORATORIJ d.d. (Croatia) aimed at lowering elevated IOP in patients with ocular hypertension and primary open-angle glaucoma (POAG) versus Cosopt® eye drops, 20 mg/mL + 5 mg/mL manufactured by Laboratoires Merck Sharp \& Dohme-Chibret, France. The main questions it aims to answer are:

* if the efficacy of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal;
* if the safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal.

A total of 110 participants were screened and randomized 1:1 to the investigational drug (Dorzotimol) group or the reference drug (Cosopt) group. 55 patients were recruited in each group.

Researchers compared the investigational drug (Dorzotimol) group with the reference drug (Cosopt) group to see if the efficacy and safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma are equal.

Conditions

  • Primary Open Angle Glaucoma of Both Eyes

Interventions

DRUG

Dorzotimol eye drops, 20 mg/mL + 5 mg/mL

Dosing schedule b.i.d.

DRUG

Cosopt eye drops, 20 mg/mL + 5 mg/mL

Dosing schedule b.i.d.

Sponsors & Collaborators

  • Jadran Galenski laboratorij d.d.

    lead INDUSTRY

Principal Investigators

  • Elmira Abdulaeva · Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2018-09-17
Completion
2018-09-17

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973318 on ClinicalTrials.gov