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Can mexidol help glaucoma patients see better?

NCT ID NCT06903156

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different doses of the drug Mexidol in 102 adults with moderate to advanced open-angle glaucoma. The goal was to see if the drug could improve vision compared to a placebo. Participants took the drug or placebo in a sequence over several months, and their vision was measured using standard eye tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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's condition/disease: presence of 20% or more false positive and/or false negative errors, large amplitude and frequency of gaze direction deviations. * The "mean deviation" (MD) score for static automatic perimetry (SAP) is -20 decibels or worse in at least one eye. * Surgical and/or laser interventions on at least one eyeball within 3 months prior to inclusion in the trial. * Significant opacities of the optical media in at least one eye, preventing assessment of the efficacy of therapy, including: severe scarring of the cornea, cataracts, consequences of uveitis. * Retinal detachment in at least one eye. * Thrombosis of a central retinal vein or artery in at least one eye. * Myopia with a length of the anteroposterior axis of the eyeball greater than 26 mm in at least one eye. * Diabetic retinopathy and other eye conditions that may affect the assessment of therapy efficacy. * Presence of a history or finding of clinically significant pathology on screening, including but not limited to those listed below: unstable angina pectoris within 3 months before inclusion in the trial; myocardial infarction within 3 months prior to inclusion in the trial; acute heart failure; severe arrhythmia requiring treatment with class Ia, Ib, Ic or III antiarrhythmic drugs; decompensation of chronic heart failure (according to the New York Heart Association classification) within 3 months before inclusion in the trial; uncontrolled arterial hypertension with systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg at screening; brain injury, stroke or transient ischaemic attack within 6 months prior to screening; occlusive blood vessel diseases; stenosing blood vessel diseases resulting in significant ischaemia of the relevant blood supply area; metabolic disorders, including severe renal insufficiency (creatinine clearance less than 30 ml/min); severe hepatic insufficiency (ALT or AST level is at least 2 times higher than the upper limit of normal values); malignant diseases of any localization with duration of remission less than 5 years according to anamnesis; II or III degree respiratory failure; community-acquired pneumonia within 6 months prior to inclusion in the trial; severe and/or uncontrolled endocrine and metabolic disorders requiring continuous medication; type 1 diabetes mellitus; type 2 diabetes mellitus, with a disease duration of 5 or more years; gastrointestinal disorders in the phase of relapse or exacerbation and requiring continuous medication. * Positive serological reactions for infections at screening: Human immunodeficiency virus (antibodies to HIV-1/2); Hepatitis B (surface antigen); Hepatitis C (antibodies to hepatitis C virus antigens); Syphilis (antibodies to Treponema pallidum). * Presence of other ophthalmological, neurological, otolaryngological or systemic diseases that may be the cause of optic nerve damage. * The presence of any other pathology that, in the opinion of the investigator, is a contraindication to the patient's participation in the trial (i.e. may adversely affect the patient's condition if he or she participates in the trial), may interfere with the conduct of the trial procedures, or affect the ability to interpret the results of the trial. In case of doubt, the investigator should consult with the trial medical monitor. * Signs of a first detected disease/pathology at screening. * Positive rapid test for IgM antibodies to SARS-CoV-2 and/or positive SARS-CoV-2 RNA using nucleic acid amplification techniques * Current or history (two years prior to screening) of alcoholism, drug abuse, drug dependence and/or substance abuse. * Mental, physical and other reasons that make it impossible to adequately assess one's behaviour and correctly comply with the conditions of the trial protocol, including a history of mental illness. * Lack of willingness to co-operate on the part of the patient. * Pregnancy and breastfeeding period. A positive pregnancy test in women of childbearing potential. * Patient participation in another clinical trial within the last 30 days. * Patient refusal to continue participation in the trial. * A decision by the Investigator or Sponsor to exclude a patient from the trial due to a significant protocol deviation/protocol violation. * A serious adverse event (SAE) or an adverse event that does not meet the criteria for seriousness, for which, in the opinion of the Investigator, further participation in the trial may be detrimental to the health or well-being of the patient, or for which withdrawal of the investigational therapy is necessary. * The need for procedures and/or adjunctive therapy not authorized by the protocol of this trial. * Allergic reaction or individual intolerance to the investigational drugs, requiring their cancellation. * Non-compliance with the therapy regime (patient's adherence to treatment with tablet form of the drug goes beyond 80%-120%, parenteral therapy - 100%), non-adherence (loss of contact with the patient with subsequent non-appearance at the visit, violation of visit dates, etc.). * Need for modification of topical hypotensive therapy. * Occurrence during the trial of conditions/diseases specified in the inclusion criteria. * Any patient condition that, in the reasonable judgement of the investigator, requires the patient to be excluded from the trial. * Erroneous inclusion. * Positive pregnancy test in a trial participant. * Positive rapid test for IgM antibodies to SARS-CoV-2 and/or positive SARS-CoV-2 RNA using nucleic acid amplification techniques. * Erroneous unblinding of trial subject's treatment group.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Budgetary healthcare institution of the Omsk region "V.P. Vyhodtsev Clinical Ophthalmological Hospital"

    Omsk, 644024, Russia

  • Federal State Autonomous Institution "Intersectoral Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Health of the RF

    Moscow, 127486, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Moscow State Medical and Dental Institute named after A.I. Evdokimov" of the Ministry of Health of the RF

    Moscow, 127473, Russia

  • Kirov Regional State Budgetary Healthcare Institution "Kirov Clinical Ophthalmological Hospital"

    Kirov, 610047, Russia

  • Private healthcare institution "Clinical hospital "RZhD-Medicine" of the city of Saratov"

    Saratov, 410004, Russia

  • Saint Petersburg State Budgetary Healthcare Institution "State Hospital No. 40 of the Kurortny District"

    Saint Petersburg, 197706, Russia

  • State Budgetary Institution of Healthcare of the Yaroslavl Region "Clinical Hospital No. 2"

    Yaroslavl, 150030, Russia

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