N/A
N=1,553
A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
Glaucoma, Primary Open Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01999348 ↗Enrolled (actual)
1,553
Serious AEs
0.1%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye — 22.18; 16.11 mmHg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fixed Combination Bimatoprost and Timolol (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) in the Study Eye |
22.18; 16.11 | — |
| SECONDARY Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale |
497; 729; 98; 67 | — |
| SECONDARY Patient Assessment of Tolerability on a 4-Point Scale |
788; 461; 45; 50; 47 | — |
| SECONDARY Physician Assessment of Tolerability on a 4-Point Scale |
809; 474; 40; 28; 40 | — |
| SECONDARY Percentage of Patients Who Discontinued Treatment |
6.47 | — |
| SECONDARY Percentage of Patients Prescribed by the Physician to Continue Treatment |
89.14 | — |
| SECONDARY Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale |
727; 542; 34; 49 | — |
Summary
The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with primary open-angle glaucoma or ocular hypertension
- Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01999348). 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.