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

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.
 
ClinicalTrials.gov Identifier: NCT01830140
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Bimatoprost 0.01% Drug: Bimatoprost 0.03% Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
Artesia, California, United States
United States, Texas
El Paso, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01830140    
Other Study ID Numbers: 192024-081
First Posted: April 12, 2013    Key Record Dates
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents