Trial Outcomes & Findings for A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens (NCT NCT02518490)

Results Overview

Subjective ratings for 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

18 participants

Primary outcome timeframe

Baseline (5 minutes post lens dispensing)

Results posted on

2020-09-22

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Sapphire Lenses 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 Lenses	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 lenses
Overall Study STARTED	18 18	18 18
Overall Study COMPLETED	17 17	17 17
Overall Study NOT COMPLETED	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sapphire Lenses 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 Lenses	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 lenses
Overall Study Withdrawal by Subject	1	1

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 Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period.
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	29 years STANDARD_DEVIATION 12 • n=17 Participants
Sex: Female, Male Female	14 Participants n=17 Participants
Sex: Female, Male Male	3 Participants n=17 Participants
Region of Enrollment United States	17 participants n=17 Participants

PRIMARY outcome

Timeframe: Baseline (5 minutes post lens dispensing)

Subjective ratings for 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 Lenses 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 Lenses	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 lenses
Subjective Ratings for Comfort After Lens Insertion	91 units on a scale Standard Deviation 11	93 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: 4 weeks

Subjective ratings for 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 Lenses 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 Lenses	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 lenses
Subjective Ratings for Comfort After Lens Insertion	88 units on a scale Standard Deviation 11	87 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: Baseline (5 minutes post lens dispensing)

Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference

Outcome measures

Outcome measures
Measure	Sapphire Lenses 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 Lenses	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 lenses
Percentage of Participants With a Lens Preference Based on Subjective Comfort Sapphire	20 percentage of participants	—
Percentage of Participants With a Lens Preference Based on Subjective Comfort No preference	30 percentage of participants	—
Percentage of Participants With a Lens Preference Based on Subjective Comfort enfilcon A	50 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference

Outcome measures

Outcome measures
Measure	Sapphire Lenses 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 Lenses	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 lenses
Percentage of Participants With a Lens Preference Based on Subjective Comfort Sapphire	10 percentage of participants	—
Percentage of Participants With a Lens Preference Based on Subjective Comfort No preference	65 percentage of participants	—
Percentage of Participants With a Lens Preference Based on Subjective Comfort enfilcon A	25 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline (5 minutes post lens dispensing)

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

Outcome measures

Outcome measures
Measure	Sapphire Lenses 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 Lenses	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 lenses
Lens Wettability	3.4 units on a scale Standard Deviation 0.4	3.4 units on a scale Standard Deviation 0.3

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 Lenses 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 Lenses	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 lenses
Lens Wettability	3.5 units on a scale Standard Deviation 0.4	3.6 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline (5 minutes post lens dispensing)

Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)

Outcome measures

Outcome measures
Measure	Sapphire Lenses 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 Lenses	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 lenses
Lens Surface Deposition	0.06 units on a scale Standard Deviation 0.17	0.03 units on a scale Standard Deviation 0.12

PRIMARY outcome

Timeframe: 4 weeks

Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)

Outcome measures

Outcome measures
Measure	Sapphire Lenses 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 Lenses	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 lenses
Lens Surface Deposition	0.21 units on a scale Standard Deviation 0.50	0.10 units on a scale Standard Deviation 0.27

Adverse Events

Sapphire Lenses

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