A Range of Contact Lenses and Care System Combinations

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03632083
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Solutions	Device: Hy-Care Contact Lens Solution; Device: Lite Contact Lens Solution; Device: fanfilcon A soft contact lens; Device: comfilcon A soft contact lens	N/A

Detailed Description

Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
• Masking: Double (Participant, Investigator)
• Masking Description: The first solution, the randomisation determines that the right lens will wear the fanfilcon A lens and the left eye will wear the comfilcon A lens for two hours of wear, with a two-day 'wash-out' period and the laterality of the lenses will be swapped for the second solution for two hours of wear. Lenses will be provided in lens cases which do not detail lens or care system information.
• Primary Purpose: Basic Science
• Official Title: A Range of Contact Lenses and Care System Combinations
• Actual Study Start Date: Sep 12, 2018
• Actual Primary Completion Date: Oct 23, 2018
• Actual Study Completion Date: Dec 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hy-Care Contact Lens Solution Each subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution.	Device: Hy-Care Contact Lens Solution; Hy-Care Contact Lens Solution; Device: fanfilcon A soft contact lens; fanfilcon A soft contact lens; Device: comfilcon A soft contact lens; comfilcon A soft contact lens
Active Comparator: Lite Contact Lens Solution Each subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Lite contact lens solution.	Device: Lite Contact Lens Solution; Lite Contact Lens Solution; Device: fanfilcon A soft contact lens; fanfilcon A soft contact lens; Device: comfilcon A soft contact lens; comfilcon A soft contact lens

Outcome Measures

Primary Outcome Measures

1. Biomicroscopy - Conjuctival Hyperaemia [Baseline (before lens insertion)]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

2. Biomicroscopy - Conjuctival Hyperaemia [2 hours]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

3. Biomicroscopy - Limbal Hyperaemia [Baseline (before contact lens insertion)]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

4. Biomicroscopy - Limbal Hyperaemia [2 hours]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

5. Biomicroscopy - Corneal Vascularisation [Baseline (before lens insertion)]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

6. Biomicroscopy - Corneal Vascularisation [2 hours]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

7. Biomicroscopy - Microcysts [Baseline (before lens insertion)]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

8. Biomicroscopy - Microcysts [2 hours]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

9. Biomicroscopy - Oedema [Baseline (before lens insertion)]

   Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

10. Biomicroscopy - Oedema [2 hours]

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

11. Biomicroscopy - Conjunctival Staining [Baseline (before lens insertion)]

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

12. Biomicroscopy - Conjunctival Staining [2 hours]

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

13. Biomicroscopy - Papillary Conjunctivitis [Baseline (before lens insertion)]

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

14. Biomicroscopy - Papillary Conjunctivitis [2 hours]

    Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

Secondary Outcome Measures

1. Comfort [Baseline 5 minutes after lens insertion]

   Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).

2. Comfort [2 hours]

   Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).

3. Dryness [2 hours]

   Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).

4. Overall Score [Baseline 5 minutes after lens insertion]

   Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).

5. Overall Score [2 hours]

   Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. They are of legal age (18) and 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 agree not to participate in other clinical research for the duration of this study.

5. They can be satisfactorily fitted with the study lens for a period of approximately 2 hours.

6. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.

7. They currently wear daily disposable soft contact lenses or have done so in the previous six months.

8. They are willing to comply with the wear schedule (approximately 2 hours on two different days)

9. They own a wearable pair of spectacles and agree to bring these to study visits.

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 currently wear reusable soft contact lenses in both eyes.

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

5. They have had cataract surgery.

6. They have had corneal refractive surgery.

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

8. They are pregnant or breast-feeding.

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

10. They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2

11. They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a

12. 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.

13. 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	Eurolens Research	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 18, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03632083
• Other Study ID Numbers: C17-635 (EX-MKTG-95)
• First Posted: Aug 15, 2018
• Last Update Posted: Aug 24, 2020
• Last Verified: Aug 1, 2020

• 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: Contact Lens Solutions; Pharmaceutical Solutions

Study Results

Participant Flow

Pre-assignment Detail	This was a randomised, double-masked, contralateral, cross-over study in which subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in a lens care product Lite or Hy-Care.

Arm/Group Title	Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Right Eye	Hy-Care - Fanfilcon A Then Lite - Comilcon A on Left Eye	Hy-Care - Fanfilcon A Then Lite - Comfilcon A on Right Eye	Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Left Eye	Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Right Eye	Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Left Eye	Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Right Eye	Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Left Eye
Arm/Group Description	Subjects were randomized to wear comfilcon A lens soaked overnight in the Hy-Care solution on the right eye for two hours then wear fanfilcon A lens soaked overnight in the Lite Solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear fanfilcon A lens soaked overnight in the Hy-Care solution on the left eye for two hours then wear comfilcon A lens soaked overnight in the Lite Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear fanfilcon A lens soaked overnight in the Hy-Care solution on the right eye for two hours then wear comfilcon A lens soaked overnight in the Lite Solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear comfilcon A lens soaked overnight in the Hy-Care solution on the left eye for two hours then wear fanfilcon A lens soaked overnight in the Lite Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear comfilcon A lens soaked overnight in the Lite solution on the right eye for two hours then wear fanfilcon A lens soaked overnight in the Hy-Care Solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear fanfilcon A lens soaked overnight in the Lite solution on the left eye for two hours then wear comfilcon A lens soaked overnight in the Hy-Care Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear fanfilcon A lens soaked overnight in the Lite solution on the right eye for two hours then wear comfilcon A lens soaked overnight in the Hy-Care solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens	Subjects were randomized to wear comfilcon A lens soaked overnight in the Lite solution on the left eye for two hours then wear fanfilcon A lens soaked overnight in the Hy-Care Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens
Period Title: First Intervention
STARTED	5	5	7	7	9	9	7	7
COMPLETED	5	5	7	7	9	9	7	7
NOT COMPLETED	0	0	0	0	0	0	0	0
Period Title: First Intervention
STARTED	5	5	7	7	9	9	7	7
COMPLETED	5	5	7	7	9	9	7	5
NOT COMPLETED	0	0	0	0	0	0	0	2

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution Contact Lens Solution: Lite contact lens solution
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.9 (16.2)
Sex: Female, Male (Count of Participants)
Female	16 57.1%
Male	12 42.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	28 100%

Outcome Measures

1. Primary Outcome

Title	Biomicroscopy - Conjuctival Hyperaemia
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.95 (0.22)	0.94 (0.23)	0.91 (0.23)	0.91 (0.21)

2. Primary Outcome

Title	Biomicroscopy - Conjuctival Hyperaemia
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	1.01 (0.21)	1.01 (0.21)	0.99 (0.24)	0.99 (0.25)

3. Primary Outcome

Title	Biomicroscopy - Limbal Hyperaemia
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before contact lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.86 (0.26)	0.85 (0.28)	0.76 (0.30)	0.76 (0.28)

4. Primary Outcome

Title	Biomicroscopy - Limbal Hyperaemia
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.90 (0.27)	0.90 (0.28)	0.81 (0.29)	0.81 (0.31)

5. Primary Outcome

Title	Biomicroscopy - Corneal Vascularisation
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.08 (0.15)	0.08 (0.15)	0.06 (0.12)	0.06 (0.12)

6. Primary Outcome

Title	Biomicroscopy - Corneal Vascularisation
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.09 (0.17)	0.09 (0.17)	0.06 (0.12)	0.05 (0.12)

7. Primary Outcome

Title	Biomicroscopy - Microcysts
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)

8. Primary Outcome

Title	Biomicroscopy - Microcysts
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)

9. Primary Outcome

Title	Biomicroscopy - Oedema
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)

10. Primary Outcome

Title	Biomicroscopy - Oedema
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)

11. Primary Outcome

Title	Biomicroscopy - Conjunctival Staining
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	0.30 (0.32)	0.34 (0.32)	0.33 (0.30)	0.33 (0.32)

12. Primary Outcome

Title	Biomicroscopy - Conjunctival Staining
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	1.00 (0.50)	0.91 (0.43)	1.16 (0.41)	1.09 (0.44)

13. Primary Outcome

Title	Biomicroscopy - Papillary Conjunctivitis
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	Baseline (before lens insertion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with each lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	1.08 (0.27)	1.06 (0.27)	1.09 (0.27)	1.08 (0.28)

14. Primary Outcome

Title	Biomicroscopy - Papillary Conjunctivitis
Description	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	1.10 (0.27)	1.08 (0.27)	1.08 (0.28)	1.07 (0.25)

15. Secondary Outcome

Title	Comfort
Description	Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Time Frame	Baseline 5 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	88.2 (11.8)	93.5 (7.2)	90.0 (12.4)	90.8 (9.0)

16. Secondary Outcome

Title	Comfort
Description	Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	90.5 (10.2)	89.9 (13.0)	92.3 (10.8)	92.0 (11.6)

17. Secondary Outcome

Title	Dryness
Description	Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	92.6 (7.7)	90.3 (12.5)	91.5 (12.5)	91.7 (12.0)

18. Secondary Outcome

Title	Overall Score
Description	Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Time Frame	Baseline 5 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	89.0 (13.4)	90.8 (12.2)	92.2 (8.2)	92.0 (8.3)

19. Secondary Outcome

Title	Overall Score
Description	Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A	Hy-Care Contact Lens Solution - Fanfilcon A	Lite Contact Lens Solution - Comfilcon A	Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Hy-Care contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens	Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens	Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
Measure Participants	28	28	28	28
Measure Eyes	28	28	28	28
Mean (Standard Deviation) [units on a scale]	90.3 (9.4)	89.1 (11.8)	91.4 (12.4)	87.1 (19.7)

Adverse Events

Time Frame	From baseline to follow up visit for an average of 2 hours, up to maximum of 14 days.
Arm/Group Title	Hy-Care Contact Lens Solution - Comfilcon A		Hy-Care Contact Lens Solution - Fanfilcon A		Lite Contact Lens Solution - Comfilcon A		Lite Contact Lens Solution - Fanfilcon A
Arm/Group Description	Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens		Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens		Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens		Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens
All Cause Mortality
	Hy-Care Contact Lens Solution - Comfilcon A		Hy-Care Contact Lens Solution - Fanfilcon A		Lite Contact Lens Solution - Comfilcon A		Lite Contact Lens Solution - Fanfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)		0/28 (0%)		0/28 (0%)
Serious Adverse Events
	Hy-Care Contact Lens Solution - Comfilcon A		Hy-Care Contact Lens Solution - Fanfilcon A		Lite Contact Lens Solution - Comfilcon A		Lite Contact Lens Solution - Fanfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)		0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Hy-Care Contact Lens Solution - Comfilcon A		Hy-Care Contact Lens Solution - Fanfilcon A		Lite Contact Lens Solution - Comfilcon A		Lite Contact Lens Solution - Fanfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)		0/28 (0%)		0/28 (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.