Primary Open-Angle GlaucomaPhase 2NCT02143843
An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product
A Phase 2 study testing Bimatoprost in people with Primary Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 10 sites in United States.
Trial summary
This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for… 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
- 75 participants
- Where
- 10 sitesUnited States
- Study dates
- 5 Jun 2014to 31 Jan 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 FSV5-002 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 FSV5-002 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Sall Medical Research Center
Artesia, California, 90701
Coastal Research Associates
Atlanta, Georgia, 30076
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27517
Ophthalmology Associates PC
Fort Worth, Texas, 76102
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Apex Eye
Madeira, Ohio, 45243
Clayton Eye Center
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
UC Davis Dept of Ophthalmology & Vision Science
Sacramento, California, 95817
Ophthalmology Consultants
St Louis, Missouri, 63131
About this study
Official title: An Open-Label Extension (OLE) Study to Evaluate the Safety of the ForSight VISION5 Product in Subjects With Open-Angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-002
This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.
- 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 used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Experimental | 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months. 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: 13 months
Secondary outcomes (1)
Change From Baseline in Mean Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (Time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Months 3, 6, 7 and 13. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal time-point, then averaged over 0, 2, and 8 hour to get the mean IOP. The change from baseline in mean IOP was calculated. The median value over the 13 month period is reported. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the last visit (Month 6) of study FSV5-002 [NCT01915940].
Measured: Baseline (Day 1) to Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start5 Jun 2014
- Primary completion31 Dec 2015
- Study completion31 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- ForSight Vision5, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Chen, PhD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143843
- Sponsor's protocol ID
- FSV5-003
- Status last verified
- Jan 2019
- First submitted
- 18 May 2014
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brandt JD, DuBiner HB, Benza R, Sall KN, Walker GA, Semba CP; Collaborators. Long-term Safety and Efficacy of a Sustained-Release Bimatoprost Ocular Ring. Ophthalmology. 2017 Oct;124(10):1565-1566. doi: 10.1016/j.ophtha.2017.04.022. Epub 2017 May 17. No abstract available.
PubMed 28528010
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension (OLE) Study to Evaluate the Safety of the ForSight VISION5 Product in Subjects With Open-Angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-002
- ClinicalTrials.gov ID
- NCT02143843
- Acronym / sponsor ID
- FSV5-003
- Conditions
- Primary Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- ForSight Vision5, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 21 May 2014 (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.
This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.
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 used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months. |
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 FSV5-002 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 FSV5-002 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 used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months. | Drug | 13 mg Bimatoprost Ocular Insert |
Primary outcome
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Time frame: 13 months
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.
1 secondary outcome
Change From Baseline in Mean Intraocular Pressure (IOP)
Time frame: Baseline (Day 1) to Month 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28528010Brandt JD, DuBiner HB, Benza R, Sall KN, Walker GA, Semba CP; Collaborators. Long-term Safety and Efficacy of a Sustained-Release Bimatoprost Ocular Ring. Ophthalmology. 2017 Oct;124(10):1565-1566. doi: 10.1016/j.ophtha.2017.04.022. Epub 2017 May 17. No abstract available.
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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
10 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 10 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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: 13 months). 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 NCT02143843, 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 26 Feb 2019.