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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT02140060
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
* IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be \>36 mmHg at any time point;
* Able to understand and sign an informed consent form;
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;
* Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;
* Chronic, recurrent or severe inflammatory eye disease;
* Ocular trauma within the past 6 months prior to the Screening Visit;
* Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;
* Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;
* Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);
* Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;
* Intraocular surgery within the past 6 months prior to the Screening Visit;
* Ocular laser surgery within the past 3 months prior to the Screening Visit;
* Any abnormality preventing reliable applanation tonometry;
* Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
* History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;
* Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator;
* Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (\> 1 g daily) salicylate therapy;
* Use of any additional topical or systemic ocular hypotensive medication during the study;
* Concurrent use of glucocorticoids administered by any route;
* Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);
* Therapy with another investigational agent within 30 days prior to the Screening Visit;
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02140060
Study Brief:
Protocol Section:
NCT02140060