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)
1 other identifier
interventional
37
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2020
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2022
CompletedResults Posted
Study results publicly available
June 8, 2023
CompletedJune 8, 2023
May 1, 2023
1.9 years
February 24, 2020
May 12, 2023
May 12, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes
8 Weeks
Study Arms (2)
Bimatoprost SR 10 μg
EXPERIMENTALParticipants 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%
OTHERParticipants 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.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Current or anticipated enrollment in another investigational drug or device study
- Females who are pregnant, nursing, or planning a pregnancy during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (6)
Trinity Research Group /ID# 232749
Dothan, Alabama, 36301, United States
The Eye Research Foundation /ID# 232694
Newport Beach, California, 92663-3637, United States
Coastal Research Associates /ID# 232798
Roswell, Georgia, 30076, United States
James D Branch MD /ID# 232718
Winston-Salem, North Carolina, 27101, United States
Scott and Christie and Associates /ID# 232747
Cranberry Township, Pennsylvania, 16066, United States
Keystone Research LTD /ID# 232665
Austin, Texas, 78731-4203, United States
Related Publications (1)
Weinreb RN, Christie WC, Medeiros FA, Craven ER, Kim K, Nguyen A, Bejanian M, Wirta DL. Single Administration of Bimatoprost Implant: Effects on 24-Hour Intraocular Pressure and 1-Year Outcomes. Ophthalmol Glaucoma. 2023 Nov-Dec;6(6):599-608. doi: 10.1016/j.ogla.2023.06.007. Epub 2023 Jun 19.
PMID: 37343625DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 24, 2020
First Posted
February 26, 2020
Study Start
June 11, 2020
Primary Completion
May 14, 2022
Study Completion
May 14, 2022
Last Updated
June 8, 2023
Results First Posted
June 8, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below
- 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.
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.