Phase 3
N=126
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01216943 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye — 22.35; -3.98 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye |
22.35; -3.98 | — |
Summary
This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
Eligibility Criteria
Inclusion Criteria
- Glaucoma and/or ocular hypertension in both eyes
- Requires IOP-lowering treatment in both eyes
Exclusion Criteria
- Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
- Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
- Use of oral, injectable or topical corticosteroids within 21 days
- Iridectomy or laser peripheral iridotomy in the study eye within 3 months
- Uncomplicated cataract surgery in the study eye within 6 months
- Incisional glaucoma surgery in the study eye within 12 months
Data sourced from ClinicalTrials.gov (NCT01216943). 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.