N/A
Completed N=235
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01068964 ↗Enrolled (actual)
235
Serious AEs
0.9%
Results posted
Jan 2012
Primary outcomePrimary: The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 — 25.20; 24.87; -9.38; -8.93 Millimeters of mercury (mmHg)
Summary
This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 |
25.20; 24.87; -9.38; -8.93 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
- Eye pressure lowering topical medications are not working
- Visual acuity is at least 0.2 in each eye
Exclusion Criteria
- Uncontrolled systemic disease
- Any other active eye disease other than glaucoma or ocular hypertension
- Significant visual field loss or evidence of progressive visual field loss within the last year
- Anticipated wearing of contact lenses during the study
- Required chronic use of other ocular medications during the study
- Eye surgery or laser treatment within 12 weeks prior to study enrollment
Data sourced from ClinicalTrials.gov (NCT01068964). 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. Informational only — not medical advice.