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

• Sponsor: ForSight Vision5, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02143843
• Collaborator: (none)
• Enrollment: 75
• Locations: 10
• Arm: 1
• Actual Duration (Months): 19.9
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-Angle Glaucoma; Ocular Hypertension	Drug: Bimatoprost	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 5, 2014
• Actual Primary Completion Date: Dec 31, 2015
• Actual Study Completion Date: Jan 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 13 mg Bimatoprost Ocular Insert 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.	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.; Other Names: "Lumigan" is the branded name of bimatoprost in eye drop form

Outcome Measures

Primary Outcome Measures

1. 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

1. 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].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Medical Research Center	Artesia	California	United States	90701
2	Scripps Clinic Torrey Pines	La Jolla	California	United States	92037
3	Eye Research Foundation	Newport Beach	California	United States	92663
4	UC Davis Dept of Ophthalmology & Vision Science	Sacramento	California	United States	95817
5	Coastal Research Associates	Atlanta	Georgia	United States	30076
6	Clayton Eye Center	Morrow	Georgia	United States	30260
7	Ophthalmology Consultants	Saint Louis	Missouri	United States	63131
8	UNC Kittner Eye Center	Chapel Hill	North Carolina	United States	27517
9	Apex Eye	Madeira	Ohio	United States	45243
10	Ophthalmology Associates PC	Fort Worth	Texas	United States	76102

Sponsors and Collaborators

• ForSight Vision5, Inc.

Investigators

• Study Director: Michelle Chen, PhD, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ForSight Vision5, Inc.
• ClinicalTrials.gov Identifier: NCT02143843
• Other Study ID Numbers: FSV5-003
• First Posted: May 21, 2014
• Last Update Posted: Feb 26, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Bimatoprost

Study Results

Participant Flow

Arm/Group Title	13 mg Bimatoprost Ocular Insert
Arm/Group 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.
Period Title: Overall Study
STARTED	75
COMPLETED	63
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	13 mg Bimatoprost Ocular Insert
Arm/Group 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.
Overall Participants	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.27 (9.21)
Sex: Female, Male (Count of Participants)
Female	44 58.7%
Male	31 41.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who had ocular inserts placed in their eyes.

Arm/Group Title	13 mg Bimatoprost Ocular Insert
Arm/Group 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.
Measure Participants	75
Ocular, Mild	53.3 71.1%
Ocular, Moderate	14.7 19.6%
Ocular, Severe	1.3 1.7%
Non-ocular, Mild	12.0 16%
Non-ocular, Moderate	18.7 24.9%
Non-ocular, Severe	1.3 1.7%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed,

Arm/Group Title	13 mg Bimatoprost Ocular Insert
Arm/Group 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.
Measure Participants	75
Median (Inter-Quartile Range) [mm Hg]	-4

Adverse Events

Time Frame	Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Arm/Group Title	13 mg Bimatoprost Ocular Insert
Arm/Group 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.
All Cause Mortality
	13 mg Bimatoprost Ocular Insert
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	13 mg Bimatoprost Ocular Insert
	Affected / at Risk (%)	# Events
Total	1/75 (1.3%)
Infections and infestations
Urinary tract infection	1/75 (1.3%)
Metabolism and nutrition disorders
Diabetes mellitus	1/75 (1.3%)
Other (Not Including Serious) Adverse Events
	13 mg Bimatoprost Ocular Insert
	Affected / at Risk (%)	# Events
Total	42/75 (56%)
Eye disorders
Conjunctival hyperaemia	15/75 (20%)
Punctate keratitis	12/75 (16%)
Eye discharge	11/75 (14.7%)
Vision blurred	9/75 (12%)
Eye pruritus	6/75 (8%)
Dry eye	5/75 (6.7%)
Foreign body sensation in eyes	5/75 (6.7%)
Ocular discomfort	4/75 (5.3%)
Lacrimation increased	9/75 (12%)
Infections and infestations
Upper respiratory tract infection	6/75 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.