N/A
N=358
An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01735214 ↗Enrolled (actual)
358
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Change From Baseline in Intraocular Pressure (IOP) in the Right Eye — -4.5 mmHg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prostaglandin Analogue -Containing IOP-Lowering Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) in the Right Eye |
-4.5 | — |
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) in the Left Eye |
-4.2 | — |
| SECONDARY Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale |
48.6; 31.6; 6.1; 1.7; 12.0 | — |
| SECONDARY Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale |
50.0; 33.0; 4.7; 2.2; 10.1 | — |
| SECONDARY Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks |
7.5 | — |
| SECONDARY Percentage of Participants Who Continue the New Treatment After 12 Weeks |
83.5 | — |
| SECONDARY Physician Assessment of Adherence to New Treatment Using a 4-Point Scale |
1.68; 4.47; 42.74; 41.34; 9.78 | — |
| SECONDARY Physician Assessment of Efficacy Using a 5-Point Scale |
24.0; 49.7; 10.9; 0.8; 4.7; 9.8 | — |
| SECONDARY Percentage of Participants Reaching Individual IOP Target After 12 Weeks |
49.7 | — |
Summary
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
- Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01735214). 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.