Trial Outcomes & Findings for A Range of Contact Lenses and Care System Combinations (NCT NCT03632083)
NCT ID: NCT03632083
Last Updated: 2020-08-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline (before lens insertion)
Results posted on
2020-08-24
Participant Flow
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.
Unit of analysis: Eyes
Participant milestones
| Measure |
Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Right Eye
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
|
Hy-Care - Fanfilcon A Then Lite - Comilcon A on Left Eye
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
|
Hy-Care - Fanfilcon A Then Lite - Comfilcon A on Right Eye
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
|
Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Left Eye
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
|
Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Right Eye
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
|
Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Left Eye
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
|
Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Right Eye
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
|
Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Left Eye
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
|
|---|---|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
5 5
|
5 5
|
7 7
|
7 7
|
9 9
|
9 9
|
7 7
|
7 7
|
|
First Intervention
COMPLETED
|
5 5
|
5 5
|
7 7
|
7 7
|
9 9
|
9 9
|
7 7
|
7 7
|
|
First Intervention
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Second Intervention
STARTED
|
5 5
|
5 5
|
7 7
|
7 7
|
9 9
|
9 9
|
7 7
|
7 7
|
|
Second Intervention
COMPLETED
|
5 5
|
5 5
|
7 7
|
7 7
|
9 9
|
9 9
|
7 7
|
5 5
|
|
Second Intervention
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
2 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Participants
n=28 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 16.2 • n=28 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=28 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Conjuctival Hyperaemia
|
0.95 units on a scale
Standard Deviation 0.22
|
0.94 units on a scale
Standard Deviation 0.23
|
0.91 units on a scale
Standard Deviation 0.23
|
0.91 units on a scale
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Conjuctival Hyperaemia
|
1.01 units on a scale
Standard Deviation 0.21
|
1.01 units on a scale
Standard Deviation 0.21
|
0.99 units on a scale
Standard Deviation 0.24
|
0.99 units on a scale
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Limbal Hyperaemia
|
0.86 units on a scale
Standard Deviation 0.26
|
0.85 units on a scale
Standard Deviation 0.28
|
0.76 units on a scale
Standard Deviation 0.30
|
0.76 units on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Limbal Hyperaemia
|
0.90 units on a scale
Standard Deviation 0.27
|
0.90 units on a scale
Standard Deviation 0.28
|
0.81 units on a scale
Standard Deviation 0.29
|
0.81 units on a scale
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Corneal Vascularisation
|
0.08 units on a scale
Standard Deviation 0.15
|
0.08 units on a scale
Standard Deviation 0.15
|
0.06 units on a scale
Standard Deviation 0.12
|
0.06 units on a scale
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Corneal Vascularisation
|
0.09 units on a scale
Standard Deviation 0.17
|
0.09 units on a scale
Standard Deviation 0.17
|
0.06 units on a scale
Standard Deviation 0.12
|
0.05 units on a scale
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Microcysts
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Microcysts
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Oedema
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Oedema
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Conjunctival Staining
|
0.30 units on a scale
Standard Deviation 0.32
|
0.34 units on a scale
Standard Deviation 0.32
|
0.33 units on a scale
Standard Deviation 0.30
|
0.33 units on a scale
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Conjunctival Staining
|
1.00 units on a scale
Standard Deviation 0.50
|
0.91 units on a scale
Standard Deviation 0.43
|
1.16 units on a scale
Standard Deviation 0.41
|
1.09 units on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Papillary Conjunctivitis
|
1.08 units on a scale
Standard Deviation 0.27
|
1.06 units on a scale
Standard Deviation 0.27
|
1.09 units on a scale
Standard Deviation 0.27
|
1.08 units on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: 2 hoursOcular 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Biomicroscopy - Papillary Conjunctivitis
|
1.10 units on a scale
Standard Deviation 0.27
|
1.08 units on a scale
Standard Deviation 0.27
|
1.08 units on a scale
Standard Deviation 0.28
|
1.07 units on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline 5 minutes after lens insertionSubjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Comfort
|
88.2 units on a scale
Standard Deviation 11.8
|
93.5 units on a scale
Standard Deviation 7.2
|
90.0 units on a scale
Standard Deviation 12.4
|
90.8 units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 2 hoursSubjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Comfort
|
90.5 units on a scale
Standard Deviation 10.2
|
89.9 units on a scale
Standard Deviation 13.0
|
92.3 units on a scale
Standard Deviation 10.8
|
92.0 units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 2 hoursSubjective 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).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Dryness
|
92.6 units on a scale
Standard Deviation 7.7
|
90.3 units on a scale
Standard Deviation 12.5
|
91.5 units on a scale
Standard Deviation 12.5
|
91.7 units on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline 5 minutes after lens insertionSubjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Overall Score
|
89.0 units on a scale
Standard Deviation 13.4
|
90.8 units on a scale
Standard Deviation 12.2
|
92.2 units on a scale
Standard Deviation 8.2
|
92.0 units on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 2 hoursSubjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).
Outcome measures
| Measure |
Hy-Care Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Hy-Care Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Comfilcon A
n=28 Eyes
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
|
Lite Contact Lens Solution - Fanfilcon A
n=28 Eyes
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
|
|---|---|---|---|---|
|
Overall Score
|
90.3 units on a scale
Standard Deviation 9.4
|
89.1 units on a scale
Standard Deviation 11.8
|
91.4 units on a scale
Standard Deviation 12.4
|
87.1 units on a scale
Standard Deviation 19.7
|
Adverse Events
Hy-Care Contact Lens Solution - Comfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hy-Care Contact Lens Solution - Fanfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lite Contact Lens Solution - Comfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lite Contact Lens Solution - Fanfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place