A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma

CM-06-04

The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).

2007-02-01

2008-05-01

2008-05-01

Completed

Early phase I

30

Inclusion Criteria: * Age ≥ 18 years * Chronic Angle Closure Glaucoma (CACG) * 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM * Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit * Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation * Peripheral anterior synechiae (PAS) Exclusion Criteria: * Traumatic damage of the anterior chamber angle * History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months * Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks * Visual Acuity ≥ 1.0 * Contact lenses wearer

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-12-06