NCT01525173

A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	0.1% brimonidine tartrate ophthalmic solution	1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
DRUG	0.01% bimatoprost ophthalmic solution	1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
DRUG	0.2% hypromellose lubricant eye drops	1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
DRUG	latanoprost 0.005% ophthalmic solution	1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-02-02
• Last updated: 2013-12-04
• Results posted: 2013-12-04

Locations

1 site across 1 country: United States