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NCT00758342 Clinical Trial

Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00758342
Other study ID # MS-06-01
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 2006
Est. completion date March 2008

Study information
Verified date February 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 37
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
• Travoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Outcome
Type Measure Description Time frame Safety issue
Primary Mean IOP (Intraocular Pressure) Screening: Week 12; (At 9 am and 4 pm time points)
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