N/A
N=235
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Open-angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01068964 ↗Enrolled (actual)
235
Serious AEs
0.9%
Results posted
Jan 2012
Primary outcome: 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 Millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution (Drug); 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2010
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 | — |
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
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.