Trial Outcomes & Findings for Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses (NCT NCT02356692)

Results Overview

Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline

Results posted on

2020-11-23

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Enfilcon A participants randomized to wear the (enfilcon A) test lens in one eye. Enfilcon A: contact lens	Senofilcon A participants randomized to wear the senofilcon A contact lens (control) in the one eye. Senofilcon A: contact lens
Overall Study STARTED	60 60	60 60
Overall Study COMPLETED	60 60	60 60
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Group n=60 Participants participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.

Outcome measures

Outcome measures
Measure	Enfilcon A n=60 eyes participants randomized to wear the (enfilcon A) test lens in one eye. enfilcon A: contact lens	Senofilcon A n=60 eyes participants randomized to wear the senofilcon A (control) lens in the one eye. senofilcon A: contact lens
Comfort at Insertion	8.7 units on a scale Standard Deviation 1.6	8.5 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 15 minutes

Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.

Outcome measures

Outcome measures
Measure	Enfilcon A n=60 Eyes participants randomized to wear the (enfilcon A) test lens in one eye. enfilcon A: contact lens	Senofilcon A n=60 Eyes participants randomized to wear the senofilcon A (control) lens in the one eye. senofilcon A: contact lens
Comfort at Insertion	8.1 units on a scale Standard Deviation 1.8	8.7 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Baseline

Population: n=59, one participant would not choose a preference at the initial insertion as both lenses were the same to them.

Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.

Outcome measures

Outcome measures
Measure	Enfilcon A n=59 Participants participants randomized to wear the (enfilcon A) test lens in one eye. enfilcon A: contact lens	Senofilcon A participants randomized to wear the senofilcon A (control) lens in the one eye. senofilcon A: contact lens
Comfort Preference Prefer Enfilcon A	30 participants	—
Comfort Preference Prefer Senofilcon A	29 participants	—

PRIMARY outcome

Timeframe: 15 minutes

Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.

Outcome measures

Outcome measures
Measure	Enfilcon A n=60 Participants participants randomized to wear the (enfilcon A) test lens in one eye. enfilcon A: contact lens	Senofilcon A participants randomized to wear the senofilcon A (control) lens in the one eye. senofilcon A: contact lens
Comfort Preference Preferred Enfilcon A	25 participants	—
Comfort Preference Preferred Senofilcon A	35 participants	—

Adverse Events

Enfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon 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

Donald Siegel, OD

CooperVision

Phone: 602 485 3414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Recipient agress to maintain Confidential Information in strict confidence, not to disclose Confidential Information to any third parties and no to use Confidential Information for any purposes execpt for Business Purpose.
Publication restrictions are in place

Restriction type: OTHER