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

Primary Purpose

Angle-Closure Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Travoprost 0.004% (Travatan)
Pilocarpine 1%
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angle-Closure Glaucoma focused on measuring IOP lowering efficacy, CACG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcon Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Travoprost 0.004% (Travatan)

Pilocarpine 1%

Arm Description

One drop in each eye, once daily at 9 AM

One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure (IOP)

Secondary Outcome Measures

Number of Patients With Peripheral Anterior Synechiae (PAS)

Full Information

First Posted
September 24, 2008
Last Updated
March 12, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00762645
Brief Title
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle-Closure Glaucoma
Keywords
IOP lowering efficacy, CACG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Travoprost 0.004% (Travatan)
Arm Type
Experimental
Arm Description
One drop in each eye, once daily at 9 AM
Arm Title
Pilocarpine 1%
Arm Type
Active Comparator
Arm Description
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004% (Travatan)
Intervention Description
One drop in each eye, once daily at 9 AM
Intervention Type
Drug
Intervention Name(s)
Pilocarpine 1%
Intervention Description
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
Time Frame
4PM at Week 12 Visit
Secondary Outcome Measure Information:
Title
Number of Patients With Peripheral Anterior Synechiae (PAS)
Time Frame
Week 12 Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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

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