Trial Outcomes & Findings for Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses (NCT NCT02423109)

Results Overview

Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Dispensing (Baseline) and 2 weeks

Results posted on

2018-01-10

Participant Flow

44 subjects were enrolled (assigned an ID per protocol), but 11 were not assigned to any group due to screen failure.

Participant milestones

Participant milestones
Measure	Randomized for Fanfilcon A Lens First, Then Enfilcon A Lens Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: toric contact lens enfilcon A: toric contact lens	Randomized for Enfilcon A Lens First, Then Fanfilcon A Lens Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: toric contact lens enfilcon A: toric contact lens
Lens 1 STARTED	19	14
Lens 1 COMPLETED	18	14
Lens 1 NOT COMPLETED	1	0
Lens 2 STARTED	18	14
Lens 2 COMPLETED	18	14
Lens 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized for Fanfilcon A Lens First, Then Enfilcon A Lens Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: toric contact lens enfilcon A: toric contact lens	Randomized for Enfilcon A Lens First, Then Fanfilcon A Lens Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. fanfilcon A: toric contact lens enfilcon A: toric contact lens
Lens 1 Adverse Event	1	0

Baseline Characteristics

Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=44 Participants All subjects were wore both fanfilcon A and enfilcon A toric lenses as either the first or second intervention.
Age, Continuous	24 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Dispensing (Baseline) and 2 weeks

Population: Analysis population differs slightly due to 1 participant who was excluded from analysis due to a protocol deviation.

Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)

Outcome measures

Outcome measures
Measure	Fanfilcon A n=15 Participants All participants who wore fanfilcon A lens pair randomly assigned as first or second pair. fanfilcon A: contact lens	Enfilcon A n=16 Participants All participants who wore enfilcon A lens pair randomly assigned as first or second pair. enfilcon A: contact lens
Comfort (Subjective Rating Scale) Dispensing	87 units on a scale Standard Deviation 17	88 units on a scale Standard Deviation 10
Comfort (Subjective Rating Scale) 2 week	79 units on a scale Standard Deviation 15	76 units on a scale Standard Deviation 18

PRIMARY outcome

Timeframe: Dispensing (Baseline) and 2 weeks

Population: Analysis population differs slightly due to protocol deviation.

Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.

Outcome measures

Outcome measures
Measure	Fanfilcon A n=31 Participants All participants who wore fanfilcon A lens pair randomly assigned as first or second pair. fanfilcon A: contact lens	Enfilcon A n=31 Participants All participants who wore enfilcon A lens pair randomly assigned as first or second pair. enfilcon A: contact lens
Comfort Preference No Preference	9 Participants	5 Participants
Comfort Preference fanfilcon A	12 Participants	14 Participants
Comfort Preference enfilcon A	10 Participants	12 Participants

Adverse Events

Fanfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Myhanh Nguyen, OD

CooperVision

Phone: 9257306716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
Publication restrictions are in place

Restriction type: OTHER