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NCT01637246 Clinical Trial

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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01637246
Other study ID # MAF/AGN/OPH/GLA/017
Secondary ID AGN-EPI-2009-02
Status Completed
Phase N/A
First received July 9, 2012
Last updated August 21, 2012
Start date April 2009
Est. completion date November 2011

Study information
Verified date August 2012
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4385
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of glaucoma or ocular hypertension

- Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Any Fixed Combination Therapy
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Patient Assessment of Tolerability Using a 4-Point Scale Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. 12 Weeks No
Secondary Physician Assessment of Tolerability Using a 4-Point Scale Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. 12 Weeks No
Secondary Percentage of Patients Who Maintained Better Compliance With Treatment Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance). 12 Weeks No
Secondary Percentage of Patients Continuing on Therapy After 12 Weeks Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No. 12 Weeks No
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