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OpenTrials
Completed

NCT Number: NCT00762645

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

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).

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Key information

Conditions

Angle-Closure Glaucoma Eye Diseases Glaucoma Glaucoma, Angle-Closure Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Travoprost 0.004% (Travatan)

Drug

One drop in each eye, once daily at 9 AM

Pilocarpine 1%

Drug

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

Primary outcomes

  1. Mean Intraocular Pressure (IOP)

    Time frame: 4PM at Week 12 Visit

Secondary outcomes

  1. Number of Patients With Peripheral Anterior Synechiae (PAS)

    Time frame: Week 12 Visit

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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