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

NCT ID: NCT00758342

Last Updated: 2023-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Intraocular Pressure

Keywords

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IOP lowering efficacy and safety of Azopt plus Travatan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Travoprost 0.004% + Brinzolamide 1.0%

Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)

Group Type EXPERIMENTAL

Travoprost 0.004% + Brinzolamide 1.0%

Intervention Type DRUG

Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)

Travoprost 0.004% + Tears Natural

Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Group Type ACTIVE_COMPARATOR

Travoprost 0.004% + Tears Natural

Intervention Type DRUG

Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Interventions

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Travoprost 0.004% + Brinzolamide 1.0%

Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)

Intervention Type DRUG

Travoprost 0.004% + Tears Natural

Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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MS-06-01

Identifier Type: -

Identifier Source: org_study_id