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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830140
First Posted: April 12, 2013
Last Update Posted: May 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01830140     History of Changes
Other Study ID Numbers: 192024-081
First Submitted: April 10, 2013
First Posted: April 12, 2013
Results First Submitted: April 21, 2015
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents