To evaluate the IOP lowering efficacy and safety of Azopt, dosed twice daily as adjunctive therapy in patients treated with Travatan once daily. The study is double masked. The patients will receive either treatment for 12 weeks...
Date First Received: September 23, 2008
Last Updated: September 24, 2008
Verified by: Alcon Research, September 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2006
Overall Status: Terminated
Estimated Enrollment: 37
Brief Summary
Official Title: “A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% as Adjunctive Therapy to Travoprost 0.004% in Patients With Chronic Angle-Closure Glaucoma”
Condition Keyword(s):
To evaluate the IOP lowering efficacy and safety of Azopt, dosed twice daily as adjunctive therapy in patients treated with Travatan once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: Travoprost 0.004% + Brinzolamide 1.0%
- Travoprost 0.004% (q.d.) + Brinzolamide 1.0% (bid)
- Drug: Travoprost 0.004% + Tears Natural
- Travoprost 0.004% (q.d.) + Tears Naturale (bid)
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Eyedrop
- Placebo Comparator: 2
- Placebo Eyedrop
Outcome Measures for this Clinical Trial
Primary Measures
- Mean IOP
- Time Frame: Screening: Week 4; Week 12; (At 9 am and 4 pm time points)
Safety Issue?: Yes
- Time Frame: Screening: Week 4; Week 12; (At 9 am and 4 pm time points)
Secondary Measures
- Best corrected visual acuity
- Time Frame: Screening; Week 4; Week 12
Safety Issue?: No
- Time Frame: Screening; Week 4; Week 12
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- ≥18 years;CACG ≥1eye;have been treated with PGA once daily ≥2 weeks prior to the screening visit and IOP=19-32 mmHg in at least one eye and ≤ 32 mmHg in both eyes;clinical stability of VA and optic nerve throughout the study
Exclusion Criteria:
- 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 and/or Azopt for 12days-4weeks;ocular surgery prior to the study
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00758342
Study ID Number: MS-06-01
ClinicalTrials.gov Identifier: NCT00758342
Health Authority: China: Ethics Committee
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