A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01830140
First received: April 10, 2013
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Bimatoprost 0.01%
Drug: Bimatoprost 0.03%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
    Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.


Enrollment: 466
Study Start Date: July 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Drug: Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Other Name: LUMIGAN® 0.01%
Active Comparator: Bimatoprost 0.03%
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Drug: Bimatoprost 0.03%
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Other Name: LUMIGAN® 0.03%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria:

  • Active ocular disease other than glaucoma or ocular hypertension
  • Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830140

Locations
United States, California
Artesia, California, United States
United States, Texas
El Paso, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01830140     History of Changes
Other Study ID Numbers: 192024-081
Study First Received: April 10, 2013
Results First Received: April 21, 2015
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015