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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: 0.1% brimonidine tartrate ophthalmic solution; Drug: latanoprost 0.005% ophthalmic solution; Drug: 0.01% bimatoprost ophthalmic solution; Drug: 0.2% hypromellose lubricant eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525173

GMA-LUM-11-019

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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137 participants in 2 patient groups

ALPHAGAN® P and LUMIGAN®

Active Comparator group

Description:

1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.

Treatment:

Drug: 0.01% bimatoprost ophthalmic solution

Drug: latanoprost 0.005% ophthalmic solution

Drug: 0.1% brimonidine tartrate ophthalmic solution

LUMIGAN® Alone

Active Comparator group

Description:

1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.

Treatment:

Drug: 0.2% hypromellose lubricant eye drops

Drug: 0.01% bimatoprost ophthalmic solution

Drug: latanoprost 0.005% ophthalmic solution