Trial Outcomes & Findings for The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens (NCT NCT02801006)

Results Overview

Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

2 weeks

Results posted on

2018-01-09

Participant Flow

Unit of analysis: EYES

Participant milestones

Participant milestones
Measure	Stenfilcon A First, Then Etafilcon A Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study.	Etafilcon A First, Then Stenfilcon A Participants randomized to wear stenfilcon A toric lens pair for two weeks then etafilcon A toric lens pair in the cross over study.
Lens 1 STARTED	22 44	19 38
Lens 1 COMPLETED	22 44	19 38
Lens 1 NOT COMPLETED	0 0	0 0
Lens 2 STARTED	22 44	19 38
Lens 2 COMPLETED	22 44	19 38
Lens 2 NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=41 Participants Total participants enrolled
Age, Continuous	29 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all

Outcome measures

Outcome measures
Measure	Stenfilcon A n=82 eyes Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study. stenfilcon A: contact lens	Etafilcon A Toric n=82 eyes Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study. etafilcon A: contact lens
Comfort	8.2 units on a scale Standard Deviation 2.0	7.4 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 2 weeks

Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all

Outcome measures

Outcome measures
Measure	Stenfilcon A n=82 eyes Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study. stenfilcon A: contact lens	Etafilcon A Toric n=82 eyes Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study. etafilcon A: contact lens
Dryness	8.0 units on a scale Standard Deviation 2.0	7.4 units on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 2 weeks

Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all

Outcome measures

Outcome measures
Measure	Stenfilcon A n=82 eyes Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study. stenfilcon A: contact lens	Etafilcon A Toric n=82 eyes Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study. etafilcon A: contact lens
Clarity of Vision	8.5 units on a scale Standard Deviation 1.9	7.8 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 2 weeks

Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision

Outcome measures

Outcome measures
Measure	Stenfilcon A n=82 eyes Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study. stenfilcon A: contact lens	Etafilcon A Toric n=82 eyes Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study. etafilcon A: contact lens
Stability of Vision	8.6 units on a scale Standard Deviation 1.8	8.0 units on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 2 weeks

Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all

Outcome measures

Outcome measures
Measure	Stenfilcon A n=82 eyes Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study. stenfilcon A: contact lens	Etafilcon A Toric n=82 eyes Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study. etafilcon A: contact lens
Lens Handling At Insertion	8.8 units on a scale Standard Deviation 1.8	7.6 units on a scale Standard Deviation 2.5
Lens Handling At Removal	7.2 units on a scale Standard Deviation 2.9	8.9 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 2 weeks

Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy

Outcome measures

Outcome measures
Measure	Stenfilcon A n=82 eyes Participants randomized to wear stenfilcon A toric lens pair (either first or second) for two weeks during the cross over study. stenfilcon A: contact lens	Etafilcon A Toric n=82 eyes Participants randomized to wear etafilcon A lens pair (either first of second) for two weeks during the cross over study. etafilcon A: contact lens
Overall Satisfaction	8.1 units on a scale Standard Deviation 2.0	7.2 units on a scale Standard Deviation 2.5

Adverse Events

Stenfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon 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

Jose Vega, O.D., MSc., FAAO

CooperVision

Phone: 9256213761

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