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

NCT01863953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2015-01-26

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Fixed-Combination Bimatoprost/Brimonidine

One drop fixed-combination bimatoprost/brimonidine in each eye twice 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.

DRUG

Vehicle Ophthalmic Solution

One drop vehicle ophthalmic solution in each eye in the morning 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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863953 on ClinicalTrials.gov