Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraocular Pressure
Intervention: Travoprost 0.004% + Brinzolamide 1.0% (Drug); Travoprost 0.004% + Tears Natural (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Alcon Research
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean IOP (Intraocular Pressure)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ≥ 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
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 (Travoprost 0. 004%) and/or Azopt (Brinzolamide 1. 0%) for 12days-4weeks
- ocular surgery prior to the study
Locations and Contacts
Alcon Call Center, Fort Worth, Texas 76134, United States
Additional Information
Starting date: May 2006
Last updated: February 23, 2010
|