Primary Open-Angle GlaucomaPhase 2OLE2NCT02537015

An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert

A Phase 2 study testing Bimatoprost in people with Primary Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 9 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 evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Bimatoprost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 9 sitesUnited States
Study dates: 10 Aug 2015to 11 Aug 2016
Phase: Phase 2
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

Completed FSV5-004 study.
Written informed consent prior to any study procedure.
Willingness to comply with the visit schedule.

Who cannot join

Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
Subjects who will require contact lens use during the study period.
Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Sall Medical Research Center
Artesia, California, 90701
Mundorf Eye Center
Charlotte, North Carolina, 28204
Vold Vision
Fayetteville, Arkansas, 72704
Cornerstone Health Care; Cornerstone Eye Care
High Point, North Carolina, 27262
University Eye Specialists
Maryville, Tennessee, 37803
Total Eye Care
Memphis, Tennessee, 38119
Clayton Eye Center
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
R&R Eye Research, LLC
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004

Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Being tested: Bimatoprost
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.

BimatoprostDrug
Also called "Lumigan" is the branded name of bimatoprost in eye drop form
Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Study groups in NCT02537015
Study group	Role	What they receive
13 mg Bimatoprost Ocular Insert	Experimental	13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks. Receives: Drug: Bimatoprost

What is being measured

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

Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Measured: Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Timeline

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

10 Aug 201511 Aug 2016

First posted1 Sep 2015 (estimated)
Study start10 Aug 2015
Primary completion11 Aug 2016
Study completion11 Aug 2016

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.
Other trials for Primary Open-Angle GlaucomaStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02537015
Sponsor's protocol ID: FSV5-005 OLE 2
Acronym: OLE2
Status last verified: Mar 2019
First submitted: 27 Aug 2015
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
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Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle

All Primary Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004
ClinicalTrials.gov ID: NCT02537015
Acronym / sponsor ID: OLE2 / FSV5-005 OLE 2
Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: ForSight Vision5, Inc.Industry (pharma, biotech, devices)
Study start: 10 Aug 2015 (actual)
Primary completion: 11 Aug 2016 (actual)
Study completion: 11 Aug 2016 (actual)
First posted: 1 Sep 2015 (estimated)
Results: Posted 26 Feb 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
13 mg Bimatoprost Ocular Insert	Experimental	Drug: Bimatoprost13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Who may qualify

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

Key inclusion criteria (3 listed)

Completed FSV5-004 study.
Written informed consent prior to any study procedure.
Willingness to comply with the visit schedule.

Key exclusion criteria (3 listed)

Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
Subjects who will require contact lens use during the study period.
Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in 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
BimatoprostAlso: "Lumigan" is the branded name of bimatoprost in eye drop formBimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.	Drug	13 mg Bimatoprost Ocular Insert

Primary outcome

Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Time frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

Results and safety

Results posted to the registry on 26 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13 mg Bimatoprost Ocular Insert	81	75

Primary outcome: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity

Time frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38). Number. Unit: percentage of participants

Measure	13 mg Bimatoprost Ocular Insert n = 81
Ocular, Mild	25.9
Ocular, Moderate	11.1
Ocular, Severe	0
Non-Ocular, Mild	6.2
Non-Ocular, Moderate	8.6
Non-Ocular, Severe	4.9

Population analysed: Safety Population included all enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed.

Adverse events

Time frame: Baseline (Day 0-enrollment in this study) to the end of study (Week 38). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13 mg Bimatoprost Ocular Insert	7 of 81 (8.6%)	20 of 81 (24.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary 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
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
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle

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.

Michelle Chen, PhD study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimatoprost in people with Primary Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 9 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 3 inclusion and 3 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Feb 2019). 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?

Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity (time frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)). 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 NCT02537015.

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 2 Apr 2019.