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

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: 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

• Registration Number: NCT01525173
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-02
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-10
• Results First Submitted: 2013-10-07
• Results First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Results First Posted: 2013-12-04
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Ocular hypertension or glaucoma in at least 1 eye
• Visual acuity of 20/100 or better in both eyes

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Exclusion Criteria

• Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
• Intraocular or glaucoma surgery in the past 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALPHAGAN® P and LUMIGAN®	0.1% brimonidine tartrate ophthalmic solution	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.
LUMIGAN® Alone	0.01% bimatoprost ophthalmic solution	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.
LUMIGAN® Alone	0.2% hypromellose lubricant eye drops	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.
ALPHAGAN® P and LUMIGAN®	latanoprost 0.005% ophthalmic solution	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.
LUMIGAN® Alone	latanoprost 0.005% ophthalmic solution	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.
ALPHAGAN® P and LUMIGAN®	0.01% bimatoprost ophthalmic solution	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)	Baseline, Week 12	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.