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Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT01217606

Last Updated: 2016-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-06-30

Brief Summary

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This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Triple Combination Therapy

Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.

Group Type EXPERIMENTAL

bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)

Intervention Type DRUG

One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.

Combigan®

Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Group Type ACTIVE_COMPARATOR

Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution

Intervention Type DRUG

One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Interventions

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bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)

One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.

Intervention Type DRUG

Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution

One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Intervention Type DRUG

Other Intervention Names

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COMBIGAN®

Eligibility Criteria

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Inclusion Criteria

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria

* Required chronic use of ocular medications during the study other than study medication
* Use of any corticosteroids within 30 days
* History of any traumatic eye surgeries
* Cataract surgery in the past 6 months
* Anticipated wearing of contact lenses during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Belfort R Jr, Paula JS, Lopes Silva MJ, Della Paolera M, Kim T, Chen MY, Goodkin ML. Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆. Clin Ther. 2020 Feb;42(2):263-275. doi: 10.1016/j.clinthera.2019.12.008. Epub 2020 Feb 20.

Reference Type DERIVED
PMID: 32089329 (View on PubMed)

Other Identifiers

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192024-062

Identifier Type: -

Identifier Source: org_study_id