A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy
This study has been completed.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01637246
First received: July 9, 2012
Last updated: August 21, 2012
Last verified: August 2012
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Purpose
This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.
| Condition | Intervention |
|---|---|
|
Glaucoma, Open-Angle Ocular Hypertension |
Drug: Any Fixed Combination Therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.
Secondary Outcome Measures:
- Patient Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]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.
- Physician Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]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.
- Percentage of Patients Who Maintained Better Compliance With Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]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).
- Percentage of Patients Continuing on Therapy After 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.
| Enrollment: | 4385 |
| Study Start Date: | April 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
POAG or OHT
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
|
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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with Primary Open Angle Glaucoma or Ocular Hypertension
Criteria
Inclusion Criteria:
- Diagnosis of glaucoma or ocular hypertension
- Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks
Exclusion Criteria:
- None
Contacts and Locations More Information
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01637246 History of Changes |
| Other Study ID Numbers: | MAF/AGN/OPH/GLA/017, AGN-EPI-2009-02 |
| Study First Received: | July 9, 2012 |
| Results First Received: | August 21, 2012 |
| Last Updated: | August 21, 2012 |
| Health Authority: | Spain: Ethics Committee |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension |
Eye Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 13, 2013