Trial Outcomes & Findings for Comparative Study of Two Marketed Spherical Soft Contact Lenses (NCT NCT01582789)

Results Overview

Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

Baseline

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Enfilcon A, Then Senofilcon A Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens	Senofilcon A, Then Enfilcon A Subjects were randomized to wear senofilcon A then enfilcon A for two weeks senofilcon A: senofilcon A daily wear soft contact lens enfilcon A: enfilcon A daily wear soft contact lens
First Intervention (14 Days) STARTED	34	27
First Intervention (14 Days) COMPLETED	34	27
First Intervention (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	34	27
Second Intervention (14 Days) COMPLETED	33	27
Second Intervention (14 Days) NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Enfilcon A, Then Senofilcon A Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens	Senofilcon A, Then Enfilcon A Subjects were randomized to wear senofilcon A then enfilcon A for two weeks senofilcon A: senofilcon A daily wear soft contact lens enfilcon A: enfilcon A daily wear soft contact lens
Second Intervention (14 Days) Withdrawal by Subject	1	0

Baseline Characteristics

Comparative Study of Two Marketed Spherical Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Group Prior to Dispense n=61 Participants All subjects prior to dispense of first set of study lenses
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: one drop out at first 2 week follow up

Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,

Outcome measures

Outcome measures
Measure	Enfilcon A n=34 Participants Subject wears enfilcon A daily wear soft contact lens as first pair	Senofilcon A n=27 Participants Subject wears senofilcon A daily wear soft contact lens as first pair
Comfort - First Intervention Insertion	9.3 units on a scale Standard Deviation 1.1	9.3 units on a scale Standard Deviation 1.1
Comfort - First Intervention Overall	9.4 units on a scale Standard Deviation 0.9	9.3 units on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Baseline

Population: one drop out at first 2 week follow up

Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,

Outcome measures

Outcome measures
Measure	Enfilcon A n=27 Participants Subject wears enfilcon A daily wear soft contact lens as first pair	Senofilcon A n=33 Participants Subject wears senofilcon A daily wear soft contact lens as first pair
Comfort - Second Intervention Overall	9.1 units on a scale Standard Deviation 1.0	9.1 units on a scale Standard Deviation 0.9
Comfort - Second Intervention Insertion	9.1 units on a scale Standard Deviation 1.1	9.1 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 2 Weeks

Population: one drop out at first 2 week follow up

Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).

Outcome measures

Outcome measures
Measure	Enfilcon A n=34 Participants Subject wears enfilcon A daily wear soft contact lens as first pair	Senofilcon A n=27 Participants Subject wears senofilcon A daily wear soft contact lens as first pair
Comfort - First Intervention Insertion	8.5 units on a scale Standard Deviation 1.8	8.3 units on a scale Standard Deviation 2.0
Comfort - First Intervention End of day	7.2 units on a scale Standard Deviation 2.1	7.7 units on a scale Standard Deviation 1.7
Comfort - First Intervention 2 weeks wear	7.7 units on a scale Standard Deviation 2.0	7.7 units on a scale Standard Deviation 2.1
Comfort - First Intervention Overall	7.9 units on a scale Standard Deviation 1.7	8.2 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 2 Weeks

Population: 1 subject withdrew from study.

Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).

Outcome measures

Outcome measures
Measure	Enfilcon A n=27 Participants Subject wears enfilcon A daily wear soft contact lens as first pair	Senofilcon A n=33 Participants Subject wears senofilcon A daily wear soft contact lens as first pair
Comfort - Second Intervention 2 weeks wear	7.4 units on a scale Standard Deviation 1.8	7.3 units on a scale Standard Deviation 2.4
Comfort - Second Intervention Overall	7.2 units on a scale Standard Deviation 1.8	7.6 units on a scale Standard Deviation 2.4
Comfort - Second Intervention Insertion	8.5 units on a scale Standard Deviation 1.1	8.4 units on a scale Standard Deviation 1.6
Comfort - Second Intervention End of day	6.3 units on a scale Standard Deviation 2.2	7.1 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 2 Weeks

Population: one drop out at first 2 week follow up

Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.

Outcome measures

Outcome measures
Measure	Enfilcon A n=33 Participants Subject wears enfilcon A daily wear soft contact lens as first pair	Senofilcon A n=27 Participants Subject wears senofilcon A daily wear soft contact lens as first pair
Comfortable Wearing Time - First Intervention	11.5 hours Standard Deviation 3.5	10.7 hours Standard Deviation 3.2

PRIMARY outcome

Timeframe: 2 Weeks

Population: one drop out at first 2 week follow up

Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.

Outcome measures

Outcome measures
Measure	Enfilcon A n=27 Participants Subject wears enfilcon A daily wear soft contact lens as first pair	Senofilcon A n=33 Participants Subject wears senofilcon A daily wear soft contact lens as first pair
Comfortable Wearing Time - Second Intervention	10.1 hours Standard Deviation 3.0	11 hours Standard Deviation 3.9

Adverse Events

Enfilcon A/Senofilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A/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

Don Siegel, OD

CooperVision, US

Phone: 623-544-3877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor. Assuming that the product is marketed, it is the intention of the sponsor to publish the results of the study.
Publication restrictions are in place

Restriction type: OTHER