N/A
N=4,385
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01637246 ↗Enrolled (actual)
4,385
Serious AEs
0.1%
Results posted
Sep 2012
Primary outcome: Primary: Change From Baseline in Intraocular Pressure (IOP) — 21.72; -4.93; 21.59; -4.88 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Any Fixed Combination Therapy (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) |
21.72; -4.93; 21.59; -4.88 | — |
| SECONDARY Patient Assessment of Tolerability Using a 4-Point Scale |
79.2 | — |
| SECONDARY Physician Assessment of Tolerability Using a 4-Point Scale |
87.6 | — |
| SECONDARY Percentage of Patients Who Maintained Better Compliance With Treatment |
33.5 | — |
| SECONDARY Percentage of Patients Continuing on Therapy After 12 Weeks |
92.9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01637246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.