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Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT01177098

Last Updated: 2013-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-02-29

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

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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bimatoprost/timolol formulation A

One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

Group Type EXPERIMENTAL

bimatoprost /timolol formulation A fixed combination ophthalmic solution

Intervention Type DRUG

One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

bimatoprost/timolol fixed combination ophthalmic solution

One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Group Type ACTIVE_COMPARATOR

bimatoprost/timolol fixed combination ophthalmic solution

Intervention Type DRUG

One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Interventions

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bimatoprost /timolol formulation A fixed combination ophthalmic solution

One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

Intervention Type DRUG

bimatoprost/timolol fixed combination ophthalmic solution

One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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GANFORT®

Eligibility Criteria

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Inclusion Criteria

* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye

Exclusion Criteria

* Active or recurrent eye disease that would interfere with interpretation of study data in either eye
* History of any eye surgery or laser in either eye within 6 months
* Required chronic use of other eye medications during the study
* Anticipated wearing of contact lenses during the study.
* Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
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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Artesia, California, United States

Site Status

Sydney, New South Wales, Australia

Site Status

Brno, , Czechia

Site Status

Leipzig, , Germany

Site Status

Budapest, , Hungary

Site Status

Tel Aviv, , Israel

Site Status

Saint Petersburg, , Russia

Site Status

Valencia, , Spain

Site Status

London, England, United Kingdom

Site Status

Countries

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United States Australia Czechia Germany Hungary Israel Russia Spain United Kingdom

References

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Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.

Reference Type DERIVED
PMID: 24667994 (View on PubMed)

Other Identifiers

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2010-021507-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

192024-050

Identifier Type: -

Identifier Source: org_study_id