N/A
N=392
GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01628601 ↗Enrolled (actual)
392
Serious AEs
0.3%
Results posted
Sep 2012
Primary outcome: Primary: Change From Baseline in Intraocular Pressure (IOP) — 22.0; -6.0; 22.0; -6.0 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fixed combination 0.3 mg bimatoprost and 5 mg timolol (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) |
22.0; -6.0; 22.0; -6.0 | — |
| SECONDARY Physician Assessment of Tolerability Using a 4-Point Scale |
340 | — |
| SECONDARY Patient Assessment of Tolerability Using a 4-Point Scale |
319 | — |
| SECONDARY Physician Assessment of Adherence to GANfort® |
112 | — |
| SECONDARY Patients Continuing With GANfort® After 18 Weeks |
329 | — |
Summary
This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary open angle glaucoma or ocular hypertension
- Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01628601). 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.