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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143843
• Other study ID #: FSV5-003
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2014
• Est. completion date: January 31, 2016

Study information

• Verified date: January 2019
• Source: ForSight Vision5, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 another 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-Angle Glaucoma

Intervention

Drug:
• Bimatoprost
Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.

Locations

Country	Name	City	State
United States	Sall Medical Research Center	Artesia	California
United States	Coastal Research Associates	Atlanta	Georgia
United States	UNC Kittner Eye Center	Chapel Hill	North Carolina
United States	Ophthalmology Associates PC	Fort Worth	Texas
United States	Scripps Clinic Torrey Pines	La Jolla	California
United States	Apex Eye	Madeira	Ohio
United States	Clayton Eye Center	Morrow	Georgia
United States	Eye Research Foundation	Newport Beach	California
United States	UC Davis Dept of Ophthalmology & Vision Science	Sacramento	California
United States	Ophthalmology Consultants	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 months
Secondary	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].	Baseline (Day 1) to Month 13