Comparative Study of Dorzol Eye Drops, 20 mg/ml Versus Trusopt® Eye Drops, 20 mg/ml

NCT05973305 | Completed Phase 3

• 1 other identifier: DORZOL-10/2015
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare efficacy and safety of Dorzol 20 mg/mL Eye Drops 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 TRUSOPT 20 MG/ML Eye Drops 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 118 participants were screened and randomized 1:1 to the investigational drug (Dorzol) group or the reference drug (Trusopt) group. 59 patients were recruited in each group. Researchers compared the investigational drug (Dorzol) group with the reference drug (Trusopt) 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 change in intraocular pressure (IOP) at visit 5 compared to baseline at visit 0

  12 weeks

Secondary Outcomes (3)

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

  12 weeks

• IOP reduction rate by more than 20%

  12 weeks

• IOP reduction rate by more than 30%

  12 weeks

Study Arms (2)

Patients with primary open-angle glaucoma receiving Dorzol 20 mg/ml

EXPERIMENTAL

Dorzol 20 mg/ml eye drops, dosing schedule t.i.d, 12 weeks

Drug: Dorzol 20 mg/ml

Patients with primary open-angle glaucoma receiving Trusopt 20 mg/ml

ACTIVE COMPARATOR

Trusopt 20 mg/ml eye drops, dosing schedule t.i.d, 12 weeks

Drug: Trusopt 20 mg/ml

Interventions

Dorzol 20 mg/ml DRUG

dosing schedule t.i.d.

Also known as: Dorzol

Patients with primary open-angle glaucoma receiving Dorzol 20 mg/ml

Trusopt 20 mg/ml DRUG

dosing schedule t.i.d.

Also known as: Trusopt

Patients with primary open-angle glaucoma receiving Trusopt 20 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.
• IOP = 21-27 mm Hg (by Goldmann applanation tonometry).
• Visual acuity 0.3 or better on the tested eye.
• 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:

• Contraindications or hypersensitivity to the active ingredient (dorzolamide) or excipients.
• 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 ˃ 27 mm Hg or ˂ 21 mm Hg as at the IOP measuring at 10.00 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).
• Chronic kidney disease (creatinine clearance ˂ 30 mL/min).
• Hyperchloremic acidosis.
• Concomitant administration of oral carbonic anhydrase inhibitors.
• Children and adolescents under 18 years.

Sponsors & Collaborators

• Jadran Galenski laboratorij d.d.: lead

Study Sites (1)

State autonomous healthcare institution 'Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan'

Kazan', Russia

Location

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Elmira Abdulaeva, PhD

  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 5, 2017
• Primary Completion: April 5, 2017
• Study Completion: September 1, 2018
• Last Updated: August 2, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)