Trial Outcomes & Findings for A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems (NCT NCT04195581)

NCT ID: NCT04195581

Last Updated: 2021-06-11

Results Overview

Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: One Month
• Results posted on: 2021-06-11

Participant Flow

Participant milestones

Measure	All Participants Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).
Comfilcon A With All in One Light STARTED	28
Comfilcon A With All in One Light COMPLETED	24
Comfilcon A With All in One Light NOT COMPLETED	4
Comfilcon A With Hy-Care STARTED	30
Comfilcon A With Hy-Care COMPLETED	25
Comfilcon A With Hy-Care NOT COMPLETED	5
Comfilcon A With Refine One Step STARTED	25
Comfilcon A With Refine One Step COMPLETED	24
Comfilcon A With Refine One Step NOT COMPLETED	1
Fanfilcon A With All in One Light STARTED	28
Fanfilcon A With All in One Light COMPLETED	27
Fanfilcon A With All in One Light NOT COMPLETED	1
Fanfilcon A With Hy-Care STARTED	28
Fanfilcon A With Hy-Care COMPLETED	25
Fanfilcon A With Hy-Care NOT COMPLETED	3
Fanfilcon A With Refine One Step STARTED	29
Fanfilcon A With Refine One Step COMPLETED	27
Fanfilcon A With Refine One Step NOT COMPLETED	2

Reasons for withdrawal

Measure	All Participants Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).
Comfilcon A With All in One Light Withdrawal by Subject	4
Comfilcon A With Hy-Care Withdrawal by Subject	5
Comfilcon A With Refine One Step Withdrawal by Subject	1
Fanfilcon A With All in One Light Withdrawal by Subject	1
Fanfilcon A With Hy-Care Withdrawal by Subject	3
Fanfilcon A With Refine One Step Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=33 Participants Subjects were randomized to use each lens and solution combination for a month in random sequence; that is for a total of six months. Lenses (comfilcon A and fanfilcon A), Lens care solutions(Hy-Care, All in One Light and Refine One Step).
Age, Categorical <=18 years	0 Participants n=33 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=33 Participants
Age, Categorical >=65 years	0 Participants n=33 Participants
Age, Continuous	28.3 years STANDARD_DEVIATION 7.4 • n=33 Participants
Sex: Female, Male Female	29 Participants n=33 Participants
Sex: Female, Male Male	4 Participants n=33 Participants
Region of Enrollment United Kingdom	33 participants n=33 Participants

PRIMARY outcome

Timeframe: One Month

Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Overall Comfort	86.0 units on a scale Standard Deviation 12.0	81.6 units on a scale Standard Deviation 14.9	81.0 units on a scale Standard Deviation 17.1	87.7 units on a scale Standard Deviation 11.7	88.0 units on a scale Standard Deviation 9.5	82.7 units on a scale Standard Deviation 16.7

PRIMARY outcome

Timeframe: One Month

Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Comfort on Insertion	88.3 units on a scale Standard Deviation 12.7	85.8 units on a scale Standard Deviation 15.0	84.0 units on a scale Standard Deviation 17.1	88.6 units on a scale Standard Deviation 14.9	90.3 units on a scale Standard Deviation 10.6	87.3 units on a scale Standard Deviation 11.8

PRIMARY outcome

Timeframe: One Month

Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Comfort Before Removal	80.0 units on a scale Standard Deviation 17.2	72.8 units on a scale Standard Deviation 17.8	74.2 units on a scale Standard Deviation 19.9	79.1 units on a scale Standard Deviation 17.2	82.4 units on a scale Standard Deviation 14.2	76.1 units on a scale Standard Deviation 19.9

SECONDARY outcome

Timeframe: One Month

Population: One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution.

Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=26 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=26 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Vision	94.8 units on a scale Standard Deviation 7.7	91.4 units on a scale Standard Deviation 11.9	93.3 units on a scale Standard Deviation 9.3	90.9 units on a scale Standard Deviation 13.1	94.2 units on a scale Standard Deviation 7.7	93.4 units on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: One Month

Population: One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution.

Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=26 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=26 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Variable Vision	92.5 units on a scale Standard Deviation 9.5	92.0 units on a scale Standard Deviation 11.5	91.8 units on a scale Standard Deviation 13.2	89.8 units on a scale Standard Deviation 15.4	92.8 units on a scale Standard Deviation 9.5	92.8 units on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: One Month

Population: One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution.

Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=26 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=26 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Vision at Night	92.5 units on a scale Standard Deviation 9.4	89.4 units on a scale Standard Deviation 13.8	91.6 units on a scale Standard Deviation 12.5	89.8 units on a scale Standard Deviation 13.0	91.3 units on a scale Standard Deviation 9.2	91.4 units on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: One Month

Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Dryness	85.5 units on a scale Standard Deviation 18.2	81.4 units on a scale Standard Deviation 17.4	81.5 units on a scale Standard Deviation 20.5	86.6 units on a scale Standard Deviation 11.3	86.3 units on a scale Standard Deviation 12.7	83.3 units on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: One Month

Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Ocular Redness	96.2 units on a scale Standard Deviation 8.6	92.6 units on a scale Standard Deviation 13.7	94.2 units on a scale Standard Deviation 10.9	95.8 units on a scale Standard Deviation 8.9	96.0 units on a scale Standard Deviation 5.6	92.7 units on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: One Month

Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Burning/Stinging	93.4 units on a scale Standard Deviation 13.1	90.6 units on a scale Standard Deviation 14.7	85.7 units on a scale Standard Deviation 16.4	92.4 units on a scale Standard Deviation 14.3	95.7 units on a scale Standard Deviation 7.8	89.6 units on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: One Month

Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Ease of Lens Insertion	93.5 units on a scale Standard Deviation 9.0	91.2 units on a scale Standard Deviation 9.7	91.7 units on a scale Standard Deviation 12.4	91.6 units on a scale Standard Deviation 14.1	92.9 units on a scale Standard Deviation 9.7	91.3 units on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: One Month

Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal).

Outcome measures

Measure	Comfilcon A With All in One Light Multi-purpose Solution n=24 Participants Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=24 Participants Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=27 Participants Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=25 Participants Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=27 Participants Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Ease of Lens Removal	92.1 units on a scale Standard Deviation 13.7	92.2 units on a scale Standard Deviation 12.6	91.6 units on a scale Standard Deviation 14.0	90.9 units on a scale Standard Deviation 10.7	92.0 units on a scale Standard Deviation 11.6	89.7 units on a scale Standard Deviation 12.5

Adverse Events

Comfilcon A With Hy-Care Multi-purpose Solution

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Comfilcon A With All in One Light Multi-purpose Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A With Refine One Step Hydrogen Peroxide Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fanfilcon A With Hy-Care Multi-purpose Solution

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Fanfilcon A With All in One Light Multi-purpose Solution

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Fanfilcon A With Refine One Step Hydrogen Peroxide Solution

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Comfilcon A With Hy-Care Multi-purpose Solution n=30 participants at risk Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solutionfor a month.	Comfilcon A With All in One Light Multi-purpose Solution n=28 participants at risk Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=25 participants at risk Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=28 participants at risk Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=28 participants at risk Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solutionfor a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=29 participants at risk Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solutionfor a month.
Eye disorders Corneal Infiltrate	3.3% 1/30 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/25 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	3.6% 1/28 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/29 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).

Other adverse events

Measure	Comfilcon A With Hy-Care Multi-purpose Solution n=30 participants at risk Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solutionfor a month.	Comfilcon A With All in One Light Multi-purpose Solution n=28 participants at risk Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Comfilcon A With Refine One Step Hydrogen Peroxide Solution n=25 participants at risk Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Fanfilcon A With Hy-Care Multi-purpose Solution n=28 participants at risk Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Fanfilcon A With All in One Light Multi-purpose Solution n=28 participants at risk Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solutionfor a month.	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution n=29 participants at risk Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solutionfor a month.
Eye disorders Corneal Infiltrate	3.3% 1/30 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/25 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	3.6% 1/28 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	3.6% 1/28 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	3.4% 1/29 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).
Eye disorders Ocular Redness	0.00% 0/30 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/25 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	3.6% 1/28 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	3.4% 1/29 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).
Eye disorders Eye Irritation	3.3% 1/30 • Number of events 1 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/25 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/28 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).	0.00% 0/29 • Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).

Additional Information

Jose Vega, OD, MSc, FAAO

CooperVision, Inc

Phone: 925-621-3761

Email: JVega2@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place