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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

Page last updated: August 23, 2015

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