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

Study Overview
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Brief Summary
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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
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALPHAGAN® P and LUMIGAN®<br>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. | Drug: 0.1% brimonidine tartrate ophthalmic solution<br>* 1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.<br>* Other names: ALPHAGAN® P;Drug: 0.01% bimatoprost ophthalmic solution<br>* 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.<br>* Other names: LUMIGAN®;Drug: latanoprost 0.005% ophthalmic solution<br>* 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.<br>|
| Active Comparator: LUMIGAN® Alone<br>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. | Drug: 0.01% bimatoprost ophthalmic solution<br>* 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.<br>* Other names: LUMIGAN®;Drug: 0.2% hypromellose lubricant eye drops<br>* 1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.<br>* Other names: GenTeal ®;Drug: latanoprost 0.005% ophthalmic solution<br>* 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) | 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. | Baseline, Week 12 |