Phase 4
Completed N=137
A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
Source: ClinicalTrials.gov NCT01525173 ↗Enrolled (actual)
137
Serious AEs
2.2%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) — 22.3; 22.2; -4.7; -4.0 mm Hg
Summary
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) |
22.3; 22.2; -4.7; -4.0 | — |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or glaucoma in at least 1 eye
- Visual acuity of 20/100 or better in both eyes
Exclusion Criteria
- Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
- Intraocular or glaucoma surgery in the past 3 months
Data sourced from ClinicalTrials.gov (NCT01525173). 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.