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An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product

Primary Purpose

Primary Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost
Sponsored by
ForSight Vision5, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-Angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Completed FSV5-002 study.
  2. Written informed consent prior to any study procedure.
  3. Willingness to comply with the visit schedule.

Exclusion Criteria:

  1. Participation in an investigational drug or device study other than FSV5-002 within the past 6 months or anticipated participation during the study period.
  2. Subjects who will require contact lens use during the study period.
  3. 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.

Sites / Locations

  • Sall Medical Research Center
  • Scripps Clinic Torrey Pines
  • Eye Research Foundation
  • UC Davis Dept of Ophthalmology & Vision Science
  • Coastal Research Associates
  • Clayton Eye Center
  • Ophthalmology Consultants
  • UNC Kittner Eye Center
  • Apex Eye
  • Ophthalmology Associates PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

13 mg Bimatoprost Ocular Insert

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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].

Full Information

First Posted
May 18, 2014
Last Updated
February 1, 2019
Sponsor
ForSight Vision5, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02143843
Brief Title
An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 5, 2014 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
January 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ForSight Vision5, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 another 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
13 mg Bimatoprost Ocular Insert
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost
Other Intervention Name(s)
"Lumigan" is the branded name of bimatoprost in eye drop form
Intervention Description
Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.
Primary Outcome Measure Information:
Title
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Description
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.
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Intraocular Pressure (IOP)
Description
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].
Time Frame
Baseline (Day 1) to Month 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed FSV5-002 study. Written informed consent prior to any study procedure. Willingness to comply with the visit schedule. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Chen, PhD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Sall Medical Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Scripps Clinic Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UC Davis Dept of Ophthalmology & Vision Science
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Coastal Research Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Ophthalmology Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
UNC Kittner Eye Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Apex Eye
City
Madeira
State/Province
Ohio
ZIP/Postal Code
45243
Country
United States
Facility Name
Ophthalmology Associates PC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28528010
Citation
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.
Results Reference
derived

Learn more about this trial

An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product

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