A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04195581
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 6
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: comfilcon A; Device: fanfilcon A	N/A

Detailed Description

This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects will use each lens and solution combination for a month in random sequence for a total of six months.Subjects will use each lens and solution combination for a month in random sequence for a total of six months.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
• Actual Study Start Date: Sep 16, 2019
• Actual Primary Completion Date: May 7, 2020
• Actual Study Completion Date: May 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: comfilcon A with Hy-Care Multi-purpose solution Subjects were randomized to wear each lens and solution combination for a month.	Device: comfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Experimental: comfilcon A with All in One Light Multi-purpose solution Subjects were randomized to wear each lens and solution combination for a month.	Device: comfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Experimental: comfilcon A with Refine One Step Hydrogen Peroxide Solution Subjects were randomized to wear each lens and solution combination for a month.	Device: comfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Active Comparator: fanfilcon A with Hy-Care Multi-purpose solution Subjects were randomized to wear each lens and solution combination for a month.	Device: fanfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Active Comparator: fanfilcon A with All in One Light multi-purpose solution Subjects were randomized to wear each lens and solution combination for a month.	Device: fanfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Active Comparator: fanfilcon A with Refine One Step Hydrogen Peroxide Solution Subjects were randomized to wear each lens and solution combination for a month.	Device: fanfilcon A; Subjects were randomized to wear each lens and solution combination for a month.

Outcome Measures

Primary Outcome Measures

1. Overall Comfort [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).

2. Comfort on Insertion [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).

3. Comfort Before Removal [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).

Secondary Outcome Measures

1. Vision [One Month]

   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)

2. Variable Vision [One Month]

   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).

3. Vision at Night [One Month]

   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)

4. Dryness [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).

5. Ocular Redness [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).

6. Burning/Stinging [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).

7. Ease of Lens Insertion [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).

8. Ease of Lens Removal [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. They are aged 18-50 and have capacity to volunteer.

2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They are an existing wearer of reusable, single vision, spherical soft contact lenses.

5. They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)

6. They have a spectacle cylindrical correction of -1.00D or less in each eye.

7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They have had cataract surgery.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or breastfeeding.

8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Manchester	Manchester		United Kingdom

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Philip Morgan, MCOptom FAAO FBCLA, Eurolens Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 10, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04195581
• Other Study ID Numbers: C19-658 EX-MKTG-108
• First Posted: Dec 12, 2019
• Last Update Posted: Jun 11, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	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).
Period Title: Comfilcon A With All in One Light
STARTED	28
COMPLETED	24
NOT COMPLETED	4
Period Title: Comfilcon A With All in One Light
STARTED	30
COMPLETED	25
NOT COMPLETED	5
Period Title: Comfilcon A With All in One Light
STARTED	25
COMPLETED	24
NOT COMPLETED	1
Period Title: Comfilcon A With All in One Light
STARTED	28
COMPLETED	27
NOT COMPLETED	1
Period Title: Comfilcon A With All in One Light
STARTED	28
COMPLETED	25
NOT COMPLETED	3
Period Title: Comfilcon A With All in One Light
STARTED	29
COMPLETED	27
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	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).
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	33 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.3 (7.4)
Sex: Female, Male (Count of Participants)
Female	29 87.9%
Male	4 12.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	33 100%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	86.0 (12.0)	81.6 (14.9)	81.0 (17.1)	87.7 (11.7)	88.0 (9.5)	82.7 (16.7)

2. Primary Outcome

Title	Comfort on Insertion
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	88.3 (12.7)	85.8 (15.0)	84.0 (17.1)	88.6 (14.9)	90.3 (10.6)	87.3 (11.8)

3. Primary Outcome

Title	Comfort Before Removal
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	80.0 (17.2)	72.8 (17.8)	74.2 (19.9)	79.1 (17.2)	82.4 (14.2)	76.1 (19.9)

4. Secondary Outcome

Title	Vision
Description	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)
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

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.

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

5. Secondary Outcome

Title	Variable Vision
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	26	25	26
Mean (Standard Deviation) [units on a scale]	92.5 (9.5)	92.0 (11.5)	91.8 (13.2)	89.8 (15.4)	92.8 (9.5)	92.8 (10.9)

6. Secondary Outcome

Title	Vision at Night
Description	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)
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	26	25	26
Mean (Standard Deviation) [units on a scale]	92.5 (9.4)	89.4 (13.8)	91.6 (12.5)	89.8 (13.0)	91.3 (9.2)	91.4 (11.0)

7. Secondary Outcome

Title	Dryness
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

8. Secondary Outcome

Title	Ocular Redness
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	96.2 (8.6)	92.6 (13.7)	94.2 (10.9)	95.8 (8.9)	96.0 (5.6)	92.7 (9.3)

9. Secondary Outcome

Title	Burning/Stinging
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subject were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subject were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	93.4 (13.1)	90.6 (14.7)	85.7 (16.4)	92.4 (14.3)	95.7 (7.8)	89.6 (14.8)

10. Secondary Outcome

Title	Ease of Lens Insertion
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month..	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	93.5 (9.0)	91.2 (9.7)	91.7 (12.4)	91.6 (14.1)	92.9 (9.7)	91.3 (11.9)

11. Secondary Outcome

Title	Ease of Lens Removal
Description	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).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A With All in One Light Multi-purpose Solution	Comfilcon A With Hy-Care Multi-purpose Solution	Comfilcon A With Refine One Step Hydrogen Peroxide Solution	Fanfilcon A With All in One Light Multi-purpose Solution	Fanfilcon A With Hy-Care Multi-purpose Solution	Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with All in One Light Multipurpose solution for a month.	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.	Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.	Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.
Measure Participants	24	25	24	27	25	27
Mean (Standard Deviation) [units on a scale]	92.1 (13.7)	92.2 (12.6)	91.6 (14.0)	90.9 (10.7)	92.0 (11.6)	89.7 (12.5)

Adverse Events

Time Frame	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).
Arm/Group Title	Comfilcon A With Hy-Care Multi-purpose Solution		Comfilcon A With All in One Light Multi-purpose Solution		Comfilcon A With Refine One Step Hydrogen Peroxide Solution		Fanfilcon A With Hy-Care Multi-purpose Solution		Fanfilcon A With All in One Light Multi-purpose Solution		Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
Arm/Group Description	Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solutionfor a month.		Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month.		Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month.		Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month.		Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solutionfor a month.		Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solutionfor a month.
All Cause Mortality
	Comfilcon A With Hy-Care Multi-purpose Solution		Comfilcon A With All in One Light Multi-purpose Solution		Comfilcon A With Refine One Step Hydrogen Peroxide Solution		Fanfilcon A With Hy-Care Multi-purpose Solution		Fanfilcon A With All in One Light Multi-purpose Solution		Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/28 (0%)		0/25 (0%)		0/28 (0%)		0/28 (0%)		0/29 (0%)
Serious Adverse Events
	Comfilcon A With Hy-Care Multi-purpose Solution		Comfilcon A With All in One Light Multi-purpose Solution		Comfilcon A With Refine One Step Hydrogen Peroxide Solution		Fanfilcon A With Hy-Care Multi-purpose Solution		Fanfilcon A With All in One Light Multi-purpose Solution		Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)		0/28 (0%)		0/25 (0%)		0/28 (0%)		1/28 (3.6%)		0/29 (0%)
Eye disorders
Corneal Infiltrate	1/30 (3.3%)	1	0/28 (0%)	0	0/25 (0%)	0	0/28 (0%)	0	1/28 (3.6%)	1	0/29 (0%)	0
Other (Not Including Serious) Adverse Events
	Comfilcon A With Hy-Care Multi-purpose Solution		Comfilcon A With All in One Light Multi-purpose Solution		Comfilcon A With Refine One Step Hydrogen Peroxide Solution		Fanfilcon A With Hy-Care Multi-purpose Solution		Fanfilcon A With All in One Light Multi-purpose Solution		Fanfilcon A With Refine One Step Hydrogen Peroxide Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/30 (6.7%)		0/28 (0%)		0/25 (0%)		2/28 (7.1%)		1/28 (3.6%)		2/29 (6.9%)
Eye disorders
Corneal Infiltrate	1/30 (3.3%)	1	0/28 (0%)	0	0/25 (0%)	0	1/28 (3.6%)	1	1/28 (3.6%)	1	1/29 (3.4%)	1
Ocular Redness	0/30 (0%)	0	0/28 (0%)	0	0/25 (0%)	0	1/28 (3.6%)	1	0/28 (0%)	0	1/29 (3.4%)	1
Eye Irritation	1/30 (3.3%)	1	0/28 (0%)	0	0/25 (0%)	0	0/28 (0%)	0	0/28 (0%)	0	0/29 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.