Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2017-12-04

Brief Summary

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The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.

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Detailed Description

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This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Simbrinza + Travatan

Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution

Group Type EXPERIMENTAL

brinzolamide 1%/brimonidine 0.2% fixed combination

Intervention Type DRUG

One drop applied topically to the affected eye(s) in the morning and evening

travoprost 0.004% ophthalmic solution

Intervention Type DRUG

One drop applied topically to the affected eye(s) in the evening

Placebo + Travatan

Placebo + travoprost 0.004% ophthalmic solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One drop applied topically to the affected eye(s) in the morning and evening

travoprost 0.004% ophthalmic solution

Intervention Type DRUG

One drop applied topically to the affected eye(s) in the evening

Interventions

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brinzolamide 1%/brimonidine 0.2% fixed combination

One drop applied topically to the affected eye(s) in the morning and evening

Intervention Type DRUG

Placebo

One drop applied topically to the affected eye(s) in the morning and evening

Intervention Type DRUG

travoprost 0.004% ophthalmic solution

One drop applied topically to the affected eye(s) in the evening

Intervention Type DRUG

Other Intervention Names

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Simbrinza Travatan

Eligibility Criteria

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Inclusion Criteria

* Sign written informed consent
* Diagnosed with normal tension glaucoma
* Intraocular pressure measurements in at least 1 eye as specified in the protocol
* Willing and able to attend all study visits

Exclusion Criteria

* History of hypersensitivity to any of the study drugs
* Use of medications prohibited by the protocol
* Pregnant or nursing
* Of child-bearing potential unless using contraception, as specified in the protocol
* Any form of glaucoma other than open angle glaucoma in either eye
* Chronic, recurrent or severe inflammatory eye disease
* Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)
* Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No