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

NCT05973318 | Completed Phase 3

• 1 other identifier: DORZOTIMOL-10/2015
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Glaucoma; Intraocular pressure; Treatment

Outcome Measures

Primary Outcomes (1)

• Mean IOP change from baseline

  Mean IOP change from baseline on visit 5 comparing with visit 0

  12 weeks

Secondary Outcomes (3)

• IOP reduction rate to the target level of ≤ 18 mm Hg

  12 weeks

• IOP reduction rate greater than 20%

  12 weeks

• IOP reduction rate greater than 30%

  12 weeks

Study Arms (2)

Patients with primary open-angle glaucoma receiving Dorzotimol eye drops, 20 mg/mL + 5 mg/mL

EXPERIMENTAL

Dosing schedule b.i.d., 12 weeks

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

Patients with primary open-angle glaucoma receiving Cosopt eye drops, 20 mg/mL + 5 mg/mL

ACTIVE COMPARATOR

Dosing schedule b.i.d., 12 weeks

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

Interventions

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

Dosing schedule b.i.d.

Also known as: Dorzotimol

Patients with primary open-angle glaucoma receiving Dorzotimol eye drops, 20 mg/mL + 5 mg/mL

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

Dosing schedule b.i.d.

Also known as: Cosopt

Patients with primary open-angle glaucoma receiving Cosopt eye drops, 20 mg/mL + 5 mg/mL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or males in the age bracket of 18 to 75 years.
• Established stage I and II primary open-angle glaucoma in one or both eyes.
• Intraocular pressure (IOP) level: 22-36 mm Hg (by Goldmann applanation tonometry).
• Visual acuity 0.3 or better on the tested eye.
• Taking topical prostaglandin analogs as monotherapy at least 3 months prior to the enrollment into the study and poor IOP control (\> 21 mm Hg) or failure to achieve the target IOP, as estimated by the physician.
• Patients who have signed an informed consent to participate in the study.
• For females of child-bearing potential - a negative pregnancy test and consent to use reliable contraception methods throughout the study

You may not qualify if:

• The only eye.
• Visual acuity ˂ 0.3 after correction.
• An active infectious inflammatory process on the tested eye within 3 months prior to pre-study medical examination.
• Pronounced visual field defects (III and IV stage open-angle glaucoma).
• IOP \> 36 mm Hg or \< 22 mm Hg as at the IOP measuring at 11:00 a.m. (±1 h) in any of the eyes on the screening visit day.
• Closed or nearly closed anterior chamber angle (ACA) or history of acute angle close.
• Surgical and laser eye interventions over the last 3 months.
• Manifest ocular media opacification hindering the treatment efficacy evaluation.
• Other eye diseases that may affect dynamics of the parameters used for the treatment efficacy evaluation.
• Inflammatory conditions of the eye and appendages (blepharitis, conjunctivitis).
• Corneal dystrophies.
• The patient's participation in another clinical trial for the last 3 months.
• Sinus bradycardia.
• Second-degree and third-degree AV block.
• Cardiogenic shock.

Sponsors & Collaborators

• Jadran Galenski laboratorij d.d.: lead

Study Sites (1)

Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan

Kazan', Russia

Location

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Elmira Abdulaeva

  Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 2, 2023
• Study Start: April 10, 2017
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)