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Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT01216943

Last Updated: 2013-09-19

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

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-08-31

Brief Summary

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This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triple Combination Therapy

One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Group Type EXPERIMENTAL

bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution

Intervention Type DRUG

One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Interventions

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bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution

One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Glaucoma and/or ocular hypertension in both eyes
* Requires IOP-lowering treatment in both eyes

Exclusion Criteria

* Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
* Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
* Use of oral, injectable or topical corticosteroids within 21 days
* Iridectomy or laser peripheral iridotomy in the study eye within 3 months
* Uncomplicated cataract surgery in the study eye within 6 months
* Incisional glaucoma surgery in the study eye within 12 months
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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Coimbatore, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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192024-049

Identifier Type: -

Identifier Source: org_study_id