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

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 Overview

• Status: Completed
• Conditions: Angle-closure Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004% (Travatan); Drug: Pilocarpine 1%

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Alcon Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travoprost 0.004% (Travatan); One drop in each eye, once daily at 9 AM	Drug: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Intraocular Pressure (IOP)	4PM at Week 12 Visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Patients With Peripheral Anterior Synechiae (PAS)	Week 12 Visit

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 24, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimated): September 30, 2008

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: IOP lowering efficacy; CACG
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Travoprost; Pilocarpine
• Other Study ID Numbers: CM-06-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No