A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
1 other identifier
interventional
466
1 country
2
Brief Summary
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2013
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
May 6, 2015
CompletedMay 6, 2015
April 1, 2015
10 months
April 10, 2013
April 21, 2015
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
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
Study Arms (2)
Bimatoprost 0.01%
EXPERIMENTALBimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03%
ACTIVE COMPARATORBimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Interventions
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of glaucoma or ocular hypertension
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (2)
Unknown Facility
Artesia, California, United States
Unknown Facility
El Paso, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
July 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 6, 2015
Results First Posted
May 6, 2015
Record last verified: 2015-04