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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

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: 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 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Deerfield Beach, Florida, United States
Additional Information

Starting date: January 2012
Last updated: October 7, 2013

Page last updated: August 23, 2015

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