A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

NCT ID: NCT01863953

Last Updated: 2015-01-26

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fixed-Combination Bimatoprost/Brimonidine

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Group Type EXPERIMENTAL

Fixed-Combination Bimatoprost/Brimonidine

Intervention Type DRUG

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Bimatoprost Ophthalmic Solution 0.01% and Vehicle

One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Group Type ACTIVE_COMPARATOR

Bimatoprost Ophthalmic Solution 0.01%

Intervention Type DRUG

One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.

Vehicle Ophthalmic Solution

Intervention Type DRUG

One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Brimonidine Tartrate Ophthalmic Solution 0.2%

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Group Type ACTIVE_COMPARATOR

Brimonidine Tartrate Ophthalmic Solution 0.2%

Intervention Type DRUG

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fixed-Combination Bimatoprost/Brimonidine

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Intervention Type DRUG

Bimatoprost Ophthalmic Solution 0.01%

One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.

Intervention Type DRUG

Vehicle Ophthalmic Solution

One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Intervention Type DRUG

Brimonidine Tartrate Ophthalmic Solution 0.2%

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LUMIGAN ALPHAGAN

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of ocular hypertension or glaucoma
* Requires intraocular pressure (IOP)-lowering therapy

Exclusion Criteria

* Cataract surgery in one eye
* Ocular laser or intraocular surgery within 6 months
* Refractive surgery in either eye
* Anticipated use of contact lenses during the study
* Expected use of artificial tears during the study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Newport Beach, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

192024-082

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.