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 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: Treatment, Randomized, Double-Blind, Parallel Assignment

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Travaprost 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: 1
• Active Comparator: 2

Primary Measures

• IOP, IOP change from baseline, and percent change from baseline.
  • Time Frame: 9Am and 4Pm at Eligibility Visit and Week 12 Visit,9Am at Week 4 Visit,4Pm at Week 8 Visit
    Safety Issue?: Yes

Secondary Measures

• Peripheral anterior synechiae (PAS)
  • Time Frame: Eligibility Visit, Week 12 Visit
    Safety Issue?: Yes

Inclusion Criteria:

• Age ≥ 18Y
• CACG
• 21--35 mmHg mean IOP on Eligibility visit day at 9Am
• Peripheral iridotomy performed ≥ IM prior to the Screening visit
• Anterior chamber angle in which the trabecular meshwork is not visible for ≥1 80°in gonioscopy without indentation
• PAS

Exclusion Criteria:

• Traumatic damage of the anterior chamber angle
• History of ocular inflammation or surgery (except for iridotomy)≤ 3M
• Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12D~4W
• VA ≥ 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

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on July 02, 2009

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