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 range35 Years – 75 Years
SexALL
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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'…
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