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

Alcon Research0 sites30 target enrollmentFebruary 2007

ConditionsAngle-closure Glaucoma

InterventionsTravoprost 0.004% (Travatan)Pilocarpine 1%

DrugsTravoprost 0.004% (Travatan)Pilocarpine 1%

Overview

Phase: Phase 4
Intervention: Travoprost 0.004% (Travatan)
Conditions: Angle-closure Glaucoma
Sponsor: Alcon Research
Enrollment: 30
Primary Endpoint: Mean Intraocular Pressure (IOP)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

May 2008

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

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