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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762645
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 15, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Alcon Research

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).

Condition or disease Intervention/treatment Phase
Angle-Closure Glaucoma Drug: Travoprost 0.004% (Travatan) Drug: Pilocarpine 1% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) [ Time Frame: 4PM at Week 12 Visit ]

Secondary Outcome Measures :
  1. Number of Patients With Peripheral Anterior Synechiae (PAS) [ Time Frame: Week 12 Visit ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762645


Locations
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United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
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Responsible Party: Benny Li, Regional Scientific Clinical Affair Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00762645    
Other Study ID Numbers: CM-06-04
First Posted: September 30, 2008    Key Record Dates
Results First Posted: March 15, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Alcon Research:
IOP lowering efficacy
CACG
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Travoprost
Pilocarpine
Antihypertensive Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action