A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy
2 other identifiers
observational
4,385
1 country
1
Brief Summary
This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Typical duration for all trials
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
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedResults Posted
Study results publicly available
September 21, 2012
CompletedSeptember 21, 2012
August 1, 2012
2.6 years
July 9, 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, 12 Weeks
Secondary Outcomes (4)
Patient Assessment of Tolerability Using a 4-Point Scale
12 Weeks
Physician Assessment of Tolerability Using a 4-Point Scale
12 Weeks
Percentage of Patients Who Maintained Better Compliance With Treatment
12 Weeks
Percentage of Patients Continuing on Therapy After 12 Weeks
12 Weeks
Study Arms (1)
POAG or OHT
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Interventions
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.
Eligibility Criteria
Patients with Primary Open Angle Glaucoma or Ocular Hypertension
You may qualify if:
- Diagnosis of glaucoma or ocular hypertension
- Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Madrid, Spain
MeSH Terms
Conditions
Condition 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
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 11, 2012
Study Start
April 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
September 21, 2012
Results First Posted
September 21, 2012
Record last verified: 2012-08