A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: 0.1% brimonidine tartrate ophthalmic solution (Drug); 0.01% bimatoprost ophthalmic solution (Drug); 0.2% hypromellose lubricant eye drops (Drug); latanoprost 0.005% ophthalmic solution (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Deerfield Beach, Florida, United States
Additional Information
Starting date: January 2012
Last updated: October 7, 2013
|
