Open-Angle GlaucomaPhase 3NCT04285580

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

A Phase 3 study testing Bimatoprost SR and LUMIGAN in people with Open-Angle Glaucoma and Ocular Hypertension, run by AbbVie at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Bimatoprost SR and LUMIGAN
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 6 sitesUnited States
Study dates: 11 Jun 2020to 14 May 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Current or anticipated enrollment in another investigational drug or device study
Females who are pregnant, nursing, or planning a pregnancy during the study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

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)

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

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Bimatoprost SR, LUMIGAN
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04285580
Study group	Role	What they receive
Bimatoprost SR 10 μg	Experimental	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. Receives: Drug: Bimatoprost SR
LUMIGAN 0.01%	Other	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. Receives: Drug: LUMIGAN

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202014 May 2022

First posted26 Feb 2020
Study start11 Jun 2020
Primary completion14 May 2022
Study completion14 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04285580
Sponsor's protocol ID: 1698-304-007
Status last verified: May 2023
First submitted: 24 Feb 2020
Last updated: 8 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.
Expanded access: Available

Publications

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.
PubMed 37343625

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04285580
Acronym / sponsor ID: 1698-304-007
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 11 Jun 2020 (actual)
Primary completion: 14 May 2022 (actual)
Study completion: 14 May 2022 (actual)
First posted: 26 Feb 2020 (actual)
Results: Posted 8 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bimatoprost SR 10 μg	Experimental	Drug: Bimatoprost SRParticipants 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%	Other	Drug: LUMIGANParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

Current or anticipated enrollment in another investigational drug or device study
Females who are pregnant, nursing, or planning a pregnancy during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bimatoprost SRConsists of 1 Bimatoprost SR administration in the study eye.	Drug	Bimatoprost SR 10 μg
LUMIGANTreatment 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.	Drug	LUMIGAN 0.01%

Primary outcome

Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
Time frame: 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)
Time frame: Up to 12 Months
The number of patients who experienced one or more TEAEs

1 secondary outcome

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

Results and safety

Results posted to the registry on 8 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimatoprost SR 10 μg	31	31
LUMIGAN 0.01%	6	5

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

Time frame: 8 weeks. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost SR 10 μg n = 31	LUMIGAN 0.01% n = 5
Diurnal/Wake Period Hour 08:00	-3.7 (5.65)	-4.0 (5.27)
Diurnal/Wake Period Hour 10:00	-2.5 (4.46)	-3.2 (3.09)
Diurnal/Wake Period Hour 12:00	-2.9 (3.36)	-5.0 (2.72)
Diurnal/Wake Period Hour 14:00	-1.8 (4.31)	-4.4 (2.04)
Diurnal/Wake Period Hour 16:00	-3.3 (3.80)	-4.2 (3.01)
Diurnal/Wake Period Hour 18:00	-1.9 (4.59)	-4.2 (2.08)
Diurnal/Wake Period Hour 20:00	-2.6 (4.29)	-5.0 (2.03)
Diurnal/Wake Period Hour 22:00	-2.3 (3.66)	-2.1 (2.48)

Population analysed: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.

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

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Bimatoprost SR 10 μg n = 31	LUMIGAN 0.01% n = 6
Value	12	4

Population analysed: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimatoprost SR 10 μg	1 of 31 (3.2%)	20 of 31 (64.5%)	0 of 31
LUMIGAN 0.01%	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37343625Weinreb 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Open-Angle Glaucoma

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ABBVIE INC. study director

AbbVie

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimatoprost SR and LUMIGAN in people with Open-Angle Glaucoma and Ocular Hypertension, run by AbbVie at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04285580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.