Trial Outcomes & Findings for An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product (NCT NCT02143843)

Last Updated: 2019-02-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

13 months

Results posted on

2019-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	75
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	8
Overall Study Lack of Efficacy	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13 mg Bimatoprost Ocular Insert n=75 Participants 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.
Age, Continuous	65.27 years STANDARD_DEVIATION 9.21 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 months

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

Outcome measures

Outcome measures
Measure	13 mg Bimatoprost Ocular Insert n=75 Participants 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.
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity Ocular, Mild	53.3 percentage of participants
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity Ocular, Moderate	14.7 percentage of participants
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity Ocular, Severe	1.3 percentage of participants
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity Non-ocular, Mild	12.0 percentage of participants
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity Non-ocular, Moderate	18.7 percentage of participants
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity Non-ocular, Severe	1.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Month 13

Population: 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,

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 \[NCT01915940\].

Outcome measures

Outcome measures
Measure	13 mg Bimatoprost Ocular Insert n=75 Participants 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.
Change From Baseline in Mean Intraocular Pressure (IOP)	-4 mm Hg Interval -6.0 to -2.0

Adverse Events

13 mg Bimatoprost Ocular Insert

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	13 mg Bimatoprost Ocular Insert n=75 participants at risk 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.
Infections and infestations Urinary tract infection	1.3% 1/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Metabolism and nutrition disorders Diabetes mellitus	1.3% 1/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)

Other adverse events

Other adverse events
Measure	13 mg Bimatoprost Ocular Insert n=75 participants at risk 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.
Eye disorders Conjunctival hyperaemia	20.0% 15/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Punctate keratitis	16.0% 12/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Eye discharge	14.7% 11/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Vision blurred	12.0% 9/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Eye pruritus	8.0% 6/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Dry eye	6.7% 5/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Foreign body sensation in eyes	6.7% 5/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Ocular discomfort	5.3% 4/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Infections and infestations Upper respiratory tract infection	8.0% 6/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
Eye disorders Lacrimation increased	12.0% 9/75 • Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER