Efficacy and Safety of Different Dosages of Mexidol® in Patients With Primary Open-angle Glaucoma… (NCT06903156) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Different Dosages of Mexidol® in Patients With Primary Open-angle Glaucoma (POAG)
Russia102 participantsStarted 2021-11-15
Plain-language summary
The present trial is planned to investigate and identify the best dosage of investigational drugs with respect to the treatment of open-angle glaucoma. Therefore, multiple dose regimens of the investigational drug versus placebo drug are anticipated.
Who can participate
Age range
35 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:
* Patients of both sexes aged 35 to 75 years inclusive.
* Diagnosis of primary open-angle glaucoma stage II or III in both eyes.
* Intraocular pressure (IOP) compliance with ""target level"": tonometric IOP \<21 mmHg in stage II, \<19 mmHg in stage III, in both eyes.
* The patient's willingness and ability to fulfil the requirements of the protocol throughout the trial.
* Patients who signed informed consent to participate in the trial.
* For women with preserved reproductive potential, a negative pregnancy test and agreement to use adequate contraceptive methods throughout the trial.
* For men, agreement to adhere to adequate contraceptive methods for the duration of trial participation.
Exclusion Criteria:
* Individual intolerance or hypersensitivity to any of the components of the investigational medicinal products according to anamnesis data.
* Administration of nootropic, vasoactive drugs, neuroprotectants, antioxidants, metabolic drugs for 30 days prior to randomisation.
* The need to use medications that are prohibited in this trial.
* Primary open-angle glaucoma stage I or IV in at least one eye.
* Closed-angle glaucoma of at least one eye.
* The only eye.
* Diagnosis of primary open-angle glaucoma stage II or III in one eye only.
* Visual acuity less than 0.1 (with correction) in at least one eye.
* Presence of an active infectious-inflammatory process in at least one eye.
* Low reliability of SAP results in at least one eye due to the patient'…
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.
What they're measuring
1
Mean change in mean deviation (MD) in static automated perimetry (SAP) at the end of the course of therapy vs. baseline