Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)
Overview
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).
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: May 2008
Interventions
- Drug: Travoprost 0.004% (Travatan)
- One drop in each eye, once daily at 9 AM
- Drug: Pilocarpine 1%
- One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Arms, Groups and Cohorts
- Experimental: Travoprost 0.004% (Travatan)
- One drop in each eye, once daily at 9 AM
- Active Comparator: Pilocarpine 1%
- One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Clinical Trial Outcome Measures
Primary Measures
- Mean Intraocular Pressure (IOP)
- Time Frame: 4PM at Week 12 Visit
Secondary Measures
- Number of Patients With Peripheral Anterior Synechiae (PAS)
- Time Frame: Week 12 Visit
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Alcon Research
- Provider of Information About this Clinical Study
- Sponsor
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