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Clinical Trials/NCT01637246
NCT01637246CompletedNot Applicable

A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

Allergan0 sites4,385 target enrollmentStarted: April 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Allergan
Enrollment
4,385
Primary Endpoint
Change From Baseline in Intraocular Pressure (IOP)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of glaucoma or ocular hypertension
  • Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

Exclusion Criteria

  • Not provided

Arms & Interventions

POAG or OHT

Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy

Intervention: Any Fixed Combination Therapy (Drug)

Outcomes

Primary Outcomes

Change From Baseline in Intraocular Pressure (IOP)

Time Frame: Baseline, 12 Weeks

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Secondary Outcomes

  • Physician Assessment of Tolerability Using a 4-Point Scale(12 Weeks)
  • Percentage of Patients Who Maintained Better Compliance With Treatment(12 Weeks)
  • Patient Assessment of Tolerability Using a 4-Point Scale(12 Weeks)
  • Percentage of Patients Continuing on Therapy After 12 Weeks(12 Weeks)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

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