A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
2 other identifiers
observational
4,812
1 country
1
Brief Summary
This is an observational study and will evaluate IOP reduction in newly diagnosed patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
Shorter than P25 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
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 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 5, 2012
CompletedSeptember 5, 2012
August 1, 2012
8 months
June 25, 2012
August 2, 2012
August 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline
Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.
Baseline, 14 Weeks
Secondary Outcomes (2)
Percentage of Patients With an IOP Reduction ≥10% From Baseline
Baseline, 14 Weeks
Percentage of Patients With an IOP Reduction ≥20% From Baseline
Baseline, 14 Weeks
Study Arms (1)
POAG or OHT
Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Interventions
Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Eligibility Criteria
Patients with primary open angle glaucoma or ocular hypertension
You may qualify if:
- Newly diagnosed with primary open angle glaucoma or ocular hypertension
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Barcelona, Spain
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
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2012
First Posted
June 27, 2012
Study Start
November 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 5, 2012
Results First Posted
September 5, 2012
Record last verified: 2012-08