Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Allergan597 enrolled

Overview

This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

597

Conditions

Glaucoma Ocular Hypertension

Interventions

Bimatoprost 0.03% Formulation B Ophthalmic SolutionDRUG

One drop administered in each eye, every evening, for 12 weeks

Bimatoprost 0.03% Ophthalmic SolutionDRUG

One drop administered in each eye, every evening, for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has ocular hypertension or glaucoma in both eyes * Requires IOP-lowering therapy in each eye Exclusion Criteria: * Active or recurrent eye disease that would interfere with interpretation of study data in either eye * History of any eye surgery or laser in either eye within 6 months * Required chronic use of other eye medications during the study * Anticipated wearing of contact lenses during the study. * Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Locations (1)

Unnamed facility

Newport Beach, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12

Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

Time frame: Baseline, Week 12

Average Eye IOP at Week 12

Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.

Time frame: Baseline, Week 12

Average Eye IOP at Week 6

Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Time frame: Week 6

Average Eye IOP at Week 2

Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Time frame: Week 2

Data from ClinicalTrials.gov

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