Study Stopped
difficulty of enrolling patients
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
1 other identifier
interventional
37
0 countries
N/A
Brief Summary
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
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 May 2006
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
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedResults Posted
Study results publicly available
February 5, 2010
CompletedDecember 5, 2023
February 1, 2010
1.8 years
September 23, 2008
September 10, 2009
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean IOP (Intraocular Pressure)
Screening: Week 12; (At 9 am and 4 pm time points)
Study Arms (2)
Travoprost 0.004% + Brinzolamide 1.0%
EXPERIMENTALTravoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Travoprost 0.004% + Tears Natural
ACTIVE COMPARATORTravoprost 0.004% (once daily) + Tears Naturale (twice daily)
Interventions
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Eligibility Criteria
You may qualify if:
- ≥ 18 years;
- CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
- have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
- clinical stability of VA (Visual Acuity) and optic nerve throughout the study
You may not qualify if:
- Abnormality restricts exam of the fundus or anderior chamber
- conjunctivitis, keratitis or uveitis
- unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
- ocular surgery prior to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
May 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
December 5, 2023
Results First Posted
February 5, 2010
Record last verified: 2010-02