Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)

Verified by: Alcon Research, March 2010
First Received: September 24, 2008 | Last Updated: March 12, 2010 | Phase: Phase 4 | Start Date: February 2007
Overall Status: Completed | Estimated Enrollment: 30
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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)...

Brief Summary

Official Title: “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”

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).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

  • 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 in this Clinical Trial

  • 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

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean Intraocular Pressure (IOP)
    • Time Frame: 4PM at Week 12 Visit
      Safety Issue?: Yes

Secondary Measures

  • Number of Patients With Peripheral Anterior Synechiae (PAS)
    • Time Frame: Week 12 Visit
      Safety Issue?: Yes

Criteria for Participation 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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Alcon Research Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00762645

Study ID Number: CM-06-04

ClinicalTrials.gov Identifier: NCT00762645

Health Authority: China: Ministry of Health

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