Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Phase 4
Terminated
- Conditions
- Intraocular Pressure
- Interventions
- Registration Number
- NCT00758342
- Lead Sponsor
- Alcon Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Travoprost 0.004% + Brinzolamide 1.0% Travoprost 0.004% + Brinzolamide 1.0% Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) Travoprost 0.004% + Tears Natural Travoprost 0.004% + Tears Natural Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
- Primary Outcome Measures
Name Time Method Mean IOP (Intraocular Pressure) Screening: Week 12; (At 9 am and 4 pm time points)
- Secondary Outcome Measures
Name Time Method