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

NCT ID: NCT01525173

Last Updated: 2013-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ALPHAGAN® P and LUMIGAN®

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.

Group Type ACTIVE_COMPARATOR

0.1% brimonidine tartrate ophthalmic solution

Intervention Type DRUG

1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.

0.01% bimatoprost ophthalmic solution

Intervention Type DRUG

1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.

latanoprost 0.005% ophthalmic solution

Intervention Type DRUG

1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

LUMIGAN® Alone

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.

Group Type ACTIVE_COMPARATOR

0.01% bimatoprost ophthalmic solution

Intervention Type DRUG

1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.

0.2% hypromellose lubricant eye drops

Intervention Type DRUG

1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.

latanoprost 0.005% ophthalmic solution

Intervention Type DRUG

1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Interventions

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0.1% brimonidine tartrate ophthalmic solution

1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.

Intervention Type DRUG

0.01% bimatoprost ophthalmic solution

1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.

Intervention Type DRUG

0.2% hypromellose lubricant eye drops

1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.

Intervention Type DRUG

latanoprost 0.005% ophthalmic solution

1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Intervention Type DRUG

Other Intervention Names

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ALPHAGAN® P LUMIGAN® GenTeal ®

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Deerfield Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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GMA-LUM-11-019

Identifier Type: -

Identifier Source: org_study_id