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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