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

Phase 3

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost SR; Drug: LUMIGAN

• Registration Number: NCT04285580
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2020-06-11
• Primary Completion: 2022-05-14
• Study Completion: 2022-05-14
• Status Verified: 2023-05
• Results First Submitted: 2023-05-12
• Results First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Results First Posted: 2023-06-08
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost SR 10 μg	Bimatoprost SR	Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
LUMIGAN 0.01%	LUMIGAN	Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes	8 weeks	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.
Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)	Up to 12 Months	The number of patients who experienced one or more TEAEs

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes	8 Weeks	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.

Trial Locations

Locations (6)

Coastal Research Associates /ID# 232798; 🇺🇸 Roswell, Georgia, United States

Scott and Christie and Associates /ID# 232747; 🇺🇸 Cranberry Township, Pennsylvania, United States

The Eye Research Foundation /ID# 232694; 🇺🇸 Newport Beach, California, United States

Trinity Research Group /ID# 232749; 🇺🇸 Dothan, Alabama, United States

James D Branch MD /ID# 232718; 🇺🇸 Winston-Salem, North Carolina, United States

Keystone Research LTD /ID# 232665; 🇺🇸 Austin, Texas, United States