A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension

AbbVie37 enrolled

Overview

This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open-Angle Glaucoma Ocular Hypertension

Interventions

Bimatoprost SRDRUG

Consists of 1 Bimatoprost SR administration in the study eye.

LUMIGANDRUG

Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment * Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months Exclusion Criteria: * Current or anticipated enrollment in another investigational drug or device study * Females who are pregnant, nursing, or planning a pregnancy during the study

Locations (6)

Trinity Research Group /ID# 232749

Dothan, Alabama, United States

The Eye Research Foundation /ID# 232694

Newport Beach, California, United States

Coastal Research Associates /ID# 232798

Roswell, Georgia, United States

James D Branch MD /ID# 232718

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Time frame: 8 weeks

Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

The number of patients who experienced one or more TEAEs

Time frame: Up to 12 Months

Secondary Outcomes

Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP.

Time frame: 8 Weeks

Data from ClinicalTrials.gov

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