A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
1 other identifier
observational
2,580
2 countries
2
Brief Summary
An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Shorter than P25 for all trials
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
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
June 13, 2014
CompletedJune 13, 2014
May 1, 2014
11 months
July 18, 2012
February 18, 2014
May 15, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Intraocular Pressure (IOP) at Baseline
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
Baseline
IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.
Week 12
Secondary Outcomes (6)
Physician Evaluation of IOP Lowering in the Study Eye(s)
Week 12
Patient Assessment of Tolerability on a 4-Point Scale
Week 12
Physician Assessment of Tolerability on a 4-Point Scale
Week 12
Physician Assessment of Patient Compliance Compared to Previous Therapy
Week 12
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
12 Weeks
- +1 more secondary outcomes
Study Arms (1)
Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Interventions
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Eligibility Criteria
Subjects with POAG and OHT
You may qualify if:
- Diagnosis of POAG or OHT
- Previous use of IOP-lowering medication
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (2)
Unknown Facility
Dresden, Germany
Unknown Facility
Amsterdam, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- 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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 20, 2012
Study Start
May 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 13, 2014
Results First Posted
June 13, 2014
Record last verified: 2014-05