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

Phase 2

Completed

• Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost

• Registration Number: NCT02143843
• Lead Sponsor: ForSight Vision5, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-18
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Study Start: 2014-06-05
• Primary Completion: 2015-12-31
• Study Completion: 2016-01-31
• Disposition First Submitted: 2017-02-14
• Disposition First Submitted QC: 2017-02-14
• Disposition First Posted: 2017-02-15
• Status Verified: 2019-01
• Results First Submitted: 2019-02-01
• Results First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Results First Posted: 2019-02-26
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
13 mg Bimatoprost Ocular Insert	Bimatoprost	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Intraocular Pressure (IOP)	Baseline (Day 1) to Month 13	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 \[NCT01915940\].

Trial Locations

Locations (10)

Scripps Clinic Torrey Pines; 🇺🇸 La Jolla, California, United States

Sall Medical Research Center; 🇺🇸 Artesia, California, United States

Coastal Research Associates; 🇺🇸 Atlanta, Georgia, United States

Ophthalmology Consultants; 🇺🇸 Saint Louis, Missouri, United States

Apex Eye; 🇺🇸 Madeira, Ohio, United States

Clayton Eye Center; 🇺🇸 Morrow, Georgia, United States

Ophthalmology Associates PC; 🇺🇸 Fort Worth, Texas, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

UC Davis Dept of Ophthalmology & Vision Science; 🇺🇸 Sacramento, California, United States

UNC Kittner Eye Center; 🇺🇸 Chapel Hill, North Carolina, United States