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

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Bimatoprost SR

LUMIGAN

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Trinity Research Group /ID# 232749
The Eye Research Foundation /ID# 232694
Coastal Research Associates /ID# 232798
James D Branch MD /ID# 232718
Scott and Christie and Associates /ID# 232747
Keystone Research LTD /ID# 232665

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Bimatoprost SR 10 μg

LUMIGAN 0.01%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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

The number of patients who experienced one or more TEAEs

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04285580

First Posted

February 24, 2020

Last Updated

May 12, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT04285580

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 11, 2020 (Actual)

Primary Completion Date

May 14, 2022 (Actual)

Study Completion Date

May 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bimatoprost SR 10 μg

Arm Type

Experimental

Arm Description

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.

Arm Title

LUMIGAN 0.01%

Arm Type

Other

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Bimatoprost SR

Intervention Description

Consists of 1 Bimatoprost SR administration in the study eye.

Intervention Type

Drug

Intervention Name(s)

LUMIGAN

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

The number of patients who experienced one or more TEAEs

Time Frame

Up to 12 Months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ABBVIE INC.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Trinity Research Group /ID# 232749

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36301

Country

United States

Facility Name

The Eye Research Foundation /ID# 232694

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663-3637

Country

United States

Facility Name

Coastal Research Associates /ID# 232798

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

James D Branch MD /ID# 232718

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27101

Country

United States

Facility Name

Scott and Christie and Associates /ID# 232747

City

Cranberry Township

State/Province

Pennsylvania

ZIP/Postal Code

16066

Country

United States

Facility Name

Keystone Research LTD /ID# 232665

City

Austin

State/Province

Texas

ZIP/Postal Code

78731-4203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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