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
1 other identifier
interventional
30
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedResults Posted
Study results publicly available
March 15, 2010
CompletedDecember 6, 2023
March 1, 2010
1.2 years
September 24, 2008
January 7, 2010
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Intraocular Pressure (IOP)
4PM at Week 12 Visit
Secondary Outcomes (1)
Number of Patients With Peripheral Anterior Synechiae (PAS)
Week 12 Visit
Study Arms (2)
Travoprost 0.004% (Travatan)
EXPERIMENTALOne drop in each eye, once daily at 9 AM
Pilocarpine 1%
ACTIVE COMPARATOROne drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Chronic Angle Closure Glaucoma (CACG)
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 30, 2008
Study Start
February 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
December 6, 2023
Results First Posted
March 15, 2010
Record last verified: 2010-03