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

NCT01525173 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2013-12-04

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01525173 on ClinicalTrials.gov