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

An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)

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 Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Bimatoprost SR; Drug: LUMIGAN

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group /ID# 232749
  • California
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation /ID# 232694
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates /ID# 232798
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • James D Branch MD /ID# 232718
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott and Christie and Associates /ID# 232747
  • Texas
    • Austin, Texas, United States, 78731-4203
      • Keystone Research LTD /ID# 232665

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimatoprost SR 10 μg; 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.	Drug: Bimatoprost SR; Consists of 1 Bimatoprost SR administration in the study eye.
Other: LUMIGAN 0.01%; 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.	Drug: LUMIGAN; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)	The number of patients who experienced one or more TEAEs	Up to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 Weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.
• To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): May 14, 2022
• Study Completion (Actual): May 14, 2022

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 1698-304-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No