Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT05973305
Eligibility Criteria:
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.
* IOP = 21-27 mm Hg (by Goldmann applanation tonometry).
* Visual acuity 0.3 or better on the tested eye.
* 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 ingredient (dorzolamide) 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 ˃ 27 mm Hg or ˂ 21 mm Hg as at the IOP measuring at 10.00 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 dynamics of the parameters used for the treatment efficacy evaluation.
* Inflammatory conditions of the eye and appendages (blepharitis, conjunctivitis).
* Chronic kidney disease (creatinine clearance ˂ 30 mL/min).
* Hyperchloremic acidosis.
* Concomitant administration of oral carbonic anhydrase inhibitors.
* Children and adolescents under 18 years.
* The patient's participation in another clinical trial for the last 3 months.
* Any systemic or mental disorder/condition (unmanageable arterial hypertension, decompensated diabetes mellitus, severe renal impairment) or clinically relevant abnormal laboratory tests at screening that, in the Investigator's opinion, may put a patient to a significant risk, or compromise the study results, or appreciably affect the possibility for the patient to participate in the study.
* A patient who is unlikely to comply with the protocol requirements, e.g., is undisposed to cooperation, and is unlikely to complete the study.
* Females and males of reproductive age refusing to use efficacious contraception methods.
* Females during pregnancy and breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05973305
Study Brief:
Protocol Section:
NCT05973305