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

January 16, 2015 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed-Combination Bimatoprost/Brimonidine
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Drug: Fixed-Combination Bimatoprost/Brimonidine
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Active Comparator: 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.
Drug: Bimatoprost Ophthalmic Solution 0.01%
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.
Other Names:
  • LUMIGAN
Drug: Vehicle Ophthalmic Solution
One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Active Comparator: Brimonidine Tartrate Ophthalmic Solution 0.2%
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Other Names:
  • ALPHAGAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
Time Frame: Baseline, Day 42
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Baseline, Day 42

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Eye Mean Diurnal IOP
Time Frame: Baseline, Day 14, Day 28
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Baseline, Day 14, Day 28
Average Eye Mean Diurnal IOP
Time Frame: Day 14, Day 28, Day 42
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.
Day 14, Day 28, Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192024-082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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