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An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)

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

Key Exclusion Criteria:

  1. Participation in an investigational drug or device study other than FSV5-004 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

  • Vold Vision
  • Sall Medical Research Center
  • Eye Research Foundation
  • Clayton Eye Center
  • Mundorf Eye Center
  • Cornerstone Health Care; Cornerstone Eye Care
  • University Eye Specialists
  • Total Eye Care
  • R&R Eye Research, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

13 mg Bimatoprost Ocular Insert

Arm Description

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.

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

Full Information

First Posted
August 27, 2015
Last Updated
March 26, 2019
Sponsor
ForSight Vision5, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02537015
Brief Title
An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Acronym
OLE2
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 10, 2015 (Actual)
Primary Completion Date
August 11, 2016 (Actual)
Study Completion Date
August 11, 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 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 Insert placed for another 26 weeks (approximately 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
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
13 mg Bimatoprost Ocular Insert
Arm Type
Experimental
Arm Description
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.
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 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.
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
Baseline (Day 0, enrollment in this study) to end of study (Week 38)
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.
Time Frame
Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
Title
Percentage of Participants by Subject-Reported Comfort Assessment Categories
Description
The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported.
Time Frame
Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
Title
Bimatoprost Ocular Insert Retention Duration
Description
Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.
Time Frame
Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Title
Percentage of Participants Who Received Rescue Treatment
Description
Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
Time Frame
Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Title
Change From Baseline in Endothelial Cell Count
Description
Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.
Time Frame
Baseline (Day 0, enrollment in this study) to end of study (Week 38)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed FSV5-004 study. Written informed consent prior to any study procedure. Willingness to comply with the visit schedule. Key Exclusion Criteria: 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.
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
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
Sall Medical Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cornerstone Health Care; Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
University Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
R&R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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