Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL … (NCT05973318) | Clinical Trial Compass
CompletedPhase 3
Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL
Russia110 participantsStarted 2017-04-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:• Contraindications or hypersensitivity to the active ingredients (dorzolamide and/or timolol) 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 \> 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 dyna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.