Phase 2
N=112
A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01863953 ↗Enrolled (actual)
112
Serious AEs
1.8%
Results posted
Jan 2015
Primary outcome: Primary: Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) — 24.54; 24.38; 24.29; -6.79 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fixed-Combination Bimatoprost/Brimonidine (Drug); Bimatoprost Ophthalmic Solution 0.01% (Drug); Vehicle Ophthalmic Solution (Drug); Brimonidine Tartrate Ophthalmic Solution 0.2% (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) |
24.54; 24.38; 24.29; -6.79; -6.63; -3.92 | — |
| SECONDARY Change From Baseline in Average Eye Mean Diurnal IOP |
24.54; 24.38; 24.29; -7.63; -6.79; -4.67 | — |
| SECONDARY Average Eye Mean Diurnal IOP |
16.91; 17.59; 19.61; 17.29; 17.40; 20.06 | — |
Summary
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ocular hypertension or glaucoma
- Requires intraocular pressure (IOP)-lowering therapy
Exclusion Criteria
- Cataract surgery in one eye
- Ocular laser or intraocular surgery within 6 months
- Refractive surgery in either eye
- Anticipated use of contact lenses during the study
- Expected use of artificial tears during the study
Data sourced from ClinicalTrials.gov (NCT01863953). 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.