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: Drug: Travoprost 0.004% + Brinzolamide 1.0%; Drug: Travoprost 0.004% + Tears Natural

• 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

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Results First Submitted: 2009-09-10
• Results First Submitted QC: 2010-01-15
• Status Verified: 2010-02
• Results First Posted: 2010-02-05
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-12-05

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)