- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01830140
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
April 21, 2015 updated by: Allergan
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
466
Phase
- Phase 3
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
-
-
California
-
Artesia, California, United States
-
-
Texas
-
El Paso, Texas, 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
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: Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
|
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Other Names:
|
Active Comparator: Bimatoprost 0.03%
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
|
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
April 10, 2013
First Submitted That Met QC Criteria
April 10, 2013
First Posted (Estimate)
April 12, 2013
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192024-081
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.
Clinical Trials on Ocular Hypertension
-
Western Galilee Hospital-NahariyaUnknown
-
Laboratoires TheaCompletedOcular Hypertension GlaucomaBulgaria
-
West Virginia UniversityUniversity of PittsburghRecruitingGlaucoma and Ocular HypertensionUnited States, United Kingdom, Canada
-
Santen Inc.Completed
-
University Hospital, GenevaTerminatedGlaucoma and Ocular HypertensionSwitzerland
-
Santen Inc.Completed
-
Maastricht University Medical CenterCompletedCorticosteroid Induced Ocular Hypertension/GlaucomaNetherlands
-
Santen Inc.CompletedA Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHTGlaucoma and Ocular HypertensionUnited States
-
Bausch & Lomb IncorporatedCompletedGlaucoma | Open Angle or Ocular HypertensionUnited States
-
Nicox Ophthalmics, Inc.CompletedGlaucoma, Open-Angle | Hypertension, OcularUnited States
Clinical Trials on Bimatoprost 0.01%
-
AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleKorea, Republic of
-
AllerganCompletedOcular Hypertension | Glaucoma, Primary Open AngleTaiwan
-
University of California, San DiegoCompletedOcular Hypertension | Glaucoma | Intraocular PressureUnited States
-
Northwestern UniversityAllerganCompletedIntraocular Pressure | Nail Growth CessationUnited States
-
AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleNetherlands
-
AllerganCompletedA Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)Ocular Hypertension | Glaucoma, Open-AngleGermany
-
Amneal Pharmaceuticals, LLCCBCC Global Inc.; Amneal EU, LimitedNot yet recruitingOcular Hypertension | Open-angle GlaucomaUnited States
-
AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleAustria
-
AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleSwitzerland
-
Amneal Pharmaceuticals, LLCCBCC Global ResearchRecruitingOcular Hypertension | Glaucoma, Open-AngleUnited States