Trial Outcomes & Findings for Evaluation of Comfilcon A and Senofilcon A Lenses (NCT NCT01695369)

Results Overview

Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

Baseline Insertion, 10 Minutes, 5 hours and 10 hours

Results posted on

2020-07-28

Participant Flow

Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.

Participant milestones

Participant milestones
Measure	Overall Study Participants Senofilcon A and Comfilcon A
Overall Study STARTED	61
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Comfilcon A and Senofilcon A Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Participants n=61 Participants Senofilcon A and Comfilcon A
Age, Customized <=18 years	0 eyes n=93 Participants
Age, Customized Between 18 and 65 years	61 eyes n=93 Participants
Age, Customized >=65 years	0 eyes n=93 Participants
Age, Continuous	26 years STANDARD_DEVIATION 6 • n=93 Participants
Sex: Female, Male Female	38 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Region of Enrollment United States	61 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline Insertion, 10 Minutes, 5 hours and 10 hours

Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

Outcome measures

Outcome measures
Measure	Comfilcon A n=61 Participants comfilcon A (CooperVision Biofinity®Sphere)	Senofilcon A n=61 Participants Senofilcon A (Vistakon Acuvue® Oasys)
Subjective Responses for Comfort Rated on a 0-100 Visual Scale. Baseline Insertion	86 units on a scale Standard Deviation 15	87 units on a scale Standard Deviation 13
Subjective Responses for Comfort Rated on a 0-100 Visual Scale. 10 Minutes	89 units on a scale Standard Deviation 14	91 units on a scale Standard Deviation 12
Subjective Responses for Comfort Rated on a 0-100 Visual Scale. 5 Hours	83 units on a scale Standard Deviation 19	84 units on a scale Standard Deviation 18
Subjective Responses for Comfort Rated on a 0-100 Visual Scale. 10 Hours	79 units on a scale Standard Deviation 23	81 units on a scale Standard Deviation 21

Adverse Events

Overall Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon 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

Jan Bergmanson, OD,PhD

University of Houston, College of Optometry, TERTC

Phone: 713-743-1950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60