Trial Outcomes & Findings for A Contralateral Dispensing Clinical Trial of Study Test Silicone Hydrogel Lens Against Enfilcon A Silicone Hydrogel Lens (NCT NCT02537717)

Results Overview

Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline (After 10 minutes of lens dispense)

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Study Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=17 Participants Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Age, Categorical <=18 years	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=17 Participants
Age, Categorical >=65 years	0 Participants n=17 Participants
Age, Continuous	28 years STANDARD_DEVIATION 10 • n=17 Participants
Sex: Female, Male Female	13 Participants n=17 Participants
Sex: Female, Male Male	4 Participants n=17 Participants
Region of Enrollment Canada	17 participants n=17 Participants

PRIMARY outcome

Timeframe: Baseline (After 10 minutes of lens dispense)

Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

Outcome measures

Outcome measures
Measure	Sapphire Lens n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Subjective Ratings of Comfort	92 units on a scale Standard Deviation 9	91 units on a scale Standard Deviation 9

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

Outcome measures

Outcome measures
Measure	Sapphire Lens n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Subjective Ratings of Comfort	80 units on a scale Standard Deviation 18	82 units on a scale Standard Deviation 8

PRIMARY outcome

Timeframe: 4 weeks

Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

Outcome measures

Outcome measures
Measure	Sapphire Lens n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Subjective Ratings of Comfort	81 units on a scale Standard Deviation 16	80 units on a scale Standard Deviation 14

PRIMARY outcome

Timeframe: Baseline (after 10 minutes of lens dispense)

Subjective comfort preference Sapphire lens, Enfilcon A, no preference

Outcome measures

Outcome measures
Measure	Sapphire Lens n=34 Eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Subjective Comfort Preference Sapphire lens	47 percentage of eyes	—
Subjective Comfort Preference enfilcon A	12 percentage of eyes	—
Subjective Comfort Preference No preference	41 percentage of eyes	—

PRIMARY outcome

Timeframe: 2 weeks

Subjective comfort preference Sapphire lens, Enfilcon A, no preference

Outcome measures

Outcome measures
Measure	Sapphire Lens n=34 Eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Subjective Comfort Preference Sapphire lens	53 percentage of eyes	—
Subjective Comfort Preference enfilcon A	18 percentage of eyes	—
Subjective Comfort Preference No preference	29 percentage of eyes	—

PRIMARY outcome

Timeframe: 4 weeks

Subjective comfort preference Sapphire lens, Enfilcon A, no preference

Outcome measures

Outcome measures
Measure	Sapphire Lens n=34 Eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Subjective Comfort Preference Sapphire lens	47 percentage of eyes	—
Subjective Comfort Preference enfilcon A	18 percentage of eyes	—
Subjective Comfort Preference No preference	35 percentage of eyes	—

PRIMARY outcome

Timeframe: Baseline (After 10 minutes of lens dispense)

Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

Outcome measures

Outcome measures
Measure	Sapphire Lens n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A n=17 Participants Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Lens Wettability	2.9 units on a scale Standard Deviation 0.7	2.6 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 2 weeks

Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

Outcome measures

Outcome measures
Measure	Sapphire Lens n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Lens Wettability	2.8 units on a scale Standard Deviation 1.0	2.8 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: 4 weeks

Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

Outcome measures

Outcome measures
Measure	Sapphire Lens n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Enfilcon A n=17 eyes Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Lens Wettability	2.9 units on a scale Standard Deviation 0.9	2.6 units on a scale Standard Deviation 1.0

Adverse Events

Sapphire Lens

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

CooperVision, Inc.

Phone: 925-730-6716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place