NCT05973305

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

Completed Phase 3 Last updated 2 August 2023

What this trial tests

Phase 3 trial testing Dorzol 20 mg/ml in Primary Open Angle Glaucoma of Both Eyes in 118 participants. Completed in 1 September 2018.

Timeline

5 April 2017

Primary endpoint
5 April 2017

1 September 2018

Quick facts

Lead sponsor	Jadran Galenski laboratorij d.d.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	118
Start date	5 April 2017
Primary completion	5 April 2017
Estimated completion	1 September 2018
Sites	1 location across Russia

Drugs / interventions tested

• Dorzol 20 mg/ml — full drug profile →
• Trusopt 20 mg/ml — full drug profile →

Conditions studied

• Primary Open Angle Glaucoma of Both Eyes — all drugs for Primary Open Angle Glaucoma of Both Eyes →

Sponsor

Jadran Galenski laboratorij d.d. — full company profile →

Who can join

Adults 18 to 75, any sex, with Primary Open Angle Glaucoma of Both Eyes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances in dorzolamide hydrochloride delivery: harnessing nanotechnology for enhanced ocular drug delivery in glaucoma management.
   Pardeshi SR, Gholap AD, Hatvate NT, Gharat KD, et al · · 2024 · cited 4× · PMID 39656411 · DOI 10.1186/s11671-024-04154-x