GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy
1 other identifier
observational
392
1 country
1
Brief Summary
This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.
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 2010
1 active site
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, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedResults Posted
Study results publicly available
September 24, 2012
CompletedSeptember 24, 2012
August 1, 2012
1.1 years
June 25, 2012
August 21, 2012
August 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.
Baseline, 18 Weeks
Secondary Outcomes (4)
Physician Assessment of Tolerability Using a 4-Point Scale
18 Weeks
Patient Assessment of Tolerability Using a 4-Point Scale
18 Weeks
Physician Assessment of Adherence to GANfort®
18 Weeks
Patients Continuing With GANfort® After 18 Weeks
18 Weeks
Study Arms (1)
POAG or OHT
Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
Interventions
Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
Eligibility Criteria
Patients with primary open angle glaucoma or ocular hypertension prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) by the physician prior to study entry
You may qualify if:
- Diagnosis of primary open angle glaucoma or ocular hypertension
- Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Vienna, Austria
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
June 25, 2012
First Posted
June 27, 2012
Study Start
May 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 24, 2012
Results First Posted
September 24, 2012
Record last verified: 2012-08