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

NCT ID: NCT00762645

Last Updated: 2023-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Angle-closure Glaucoma

Keywords

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IOP lowering efficacy CACG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Travoprost 0.004% (Travatan)

One drop in each eye, once daily at 9 AM

Group Type EXPERIMENTAL

Travoprost 0.004% (Travatan)

Intervention Type DRUG

One drop in each eye, once daily at 9 AM

Pilocarpine 1%

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

Group Type ACTIVE_COMPARATOR

Pilocarpine 1%

Intervention Type DRUG

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

Interventions

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Travoprost 0.004% (Travatan)

One drop in each eye, once daily at 9 AM

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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CM-06-04

Identifier Type: -

Identifier Source: org_study_id