Trial Outcomes & Findings for Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses (NCT NCT02131402)

NCT ID: NCT02131402

Last Updated: 2017-04-04

Results Overview

Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 1 hour post settling
• Results posted on: 2017-04-04

Participant Flow

There were 60 subjects enrolled and fitted with the study lenses. All sixty subjects completed the trial (i.e. no discontinuations).

Participant milestones

Measure	Overall Participants Flow Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses. omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Measure	Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A n=60 Participants Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses. Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.
Age, Continuous	25.78 years STANDARD_DEVIATION 5.34 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A	97 units on a scale Standard Deviation 8.2	84 units on a scale Standard Deviation 20.2

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D	96 units on a scale Standard Deviation 8.9	90 units on a scale Standard Deviation 13.7

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A	97 units on a scale Standard Deviation 6.5	86 units on a scale Standard Deviation 17.7

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D	94 units on a scale Standard Deviation 9.3	82 units on a scale Standard Deviation 18.6

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A	94 units on a scale Standard Deviation 8.5	73 units on a scale Standard Deviation 17.0

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A	94 units on a scale Standard Deviation 9.3	76 units on a scale Standard Deviation 18.7

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A	98 units on a scale Standard Deviation 4.2	76 units on a scale Standard Deviation 16.4

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D	96 units on a scale Standard Deviation 6.1	83 units on a scale Standard Deviation 18.6

PRIMARY outcome

Timeframe: 1 hours post settling

Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A	96 units on a scale Standard Deviation 6.7	78 units on a scale Standard Deviation 17.7

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Strong Enfilcon A	66.7 percentage of subjects	0.0 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Slight Enfilcon A	16.7 percentage of subjects	0.0 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A No Preference	10.0 percentage of subjects	0.0 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Slight Omafilcon A	0.0 percentage of subjects	6.7 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Strong Omafilcon A	0.0 percentage of subjects	0.0 percentage of subjects

PRIMARY outcome

Timeframe: Baseline

Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Strong Enfilcon A	38 percentage of subjects	0 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Slight Enfilcon A	22 percentage of subjects	0 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D No Preference	35 percentage of subjects	0 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Slight Ocufilcon D	0 percentage of subjects	5 percentage of subjects
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Strong Ocufilcon D	0 percentage of subjects	0 percentage of subjects

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Slight Enfilcon A	18.3 percentage of eyes	0.0 percentage of eyes
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A No Preference	18.3 percentage of eyes	0.0 percentage of eyes
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Slight Methafilcon A	0.0 percentage of eyes	5.0 percentage of eyes
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Strong Methfilcon A	0.0 percentage of eyes	3.3 percentage of eyes
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Strong Enfilcon A	55.0 percentage of eyes	0.0 percentage of eyes

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Strong Enfilcon A	67 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Slight Enfilcon A	20 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A No preference	13 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Slight Omafilcon A	0 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A Strong Omafilcon A	0 percentage of subjects	0 percentage of subjects

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Strong Enfilcon A	42 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Slight Enfilcon A	18 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D No Preference	35 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Slight Ocufilcon D	0 percentage of subjects	5 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D Strong Ocufilcon D	0 percentage of subjects	0 percentage of subjects

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Strong Enfilcon A	53 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Slight Enfilcon A	22 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A No Preference	18 percentage of subjects	0 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Slight Methafilcon A	0 percentage of subjects	7 percentage of subjects
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A Strong Methafilcon A	0 percentage of subjects	0 percentage of subjects

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A	2.0 units on a scale Standard Deviation 0	2.0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D	2.0 units on a scale Standard Deviation 0	2.0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A	2.0 units on a scale Standard Deviation 0	2.0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A	50 units on a scale Standard Deviation 1.8	50 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D	50 units on a scale Standard Deviation 0.65	50 units on a scale Standard Deviation 0.65

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A	50 units on a scale Standard Deviation 0.91	50 units on a scale Standard Deviation 0.65

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).

Outcome measures

Measure	Enfilcon A n=120 Eyes Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=120 Eyes Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A Optimum	100 percentage of eyes	100 percentage of eyes
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A Decentration acceptable	0 percentage of eyes	0 percentage of eyes
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A Decentration unacceptable	0 percentage of eyes	0 percentage of eyes

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)

Outcome measures

Measure	Enfilcon A n=120 Eyes Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=120 Eyes Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D Optimum	100 percentage of eyes	100 percentage of eyes
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D Decentration Acceptable	0 percentage of eyes	0 percentage of eyes
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D Decentration Unacceptable	0 percentage of eyes	0 percentage of eyes

PRIMARY outcome

Timeframe: 1 hour post settling

Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)

Outcome measures

Measure	Enfilcon A n=120 Eyes Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=120 Eyes Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A Decentration unacceptable	0 percentage of eyes	0 percentage of eyes
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A Optimum	100 percentage of eyes	100 percentage of eyes
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A Decentration acceptable	0 percentage of eyes	0 percentage of eyes

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A	2.6 units on a scale Standard Deviation 6.00	18 units on a scale Standard Deviation 22.6

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D	3.3 units on a scale Standard Deviation 9.5	11 units on a scale Standard Deviation 20.3

PRIMARY outcome

Timeframe: Baseline

Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A	2.0 units on a scale Standard Deviation 4.0	15 units on a scale Standard Deviation 19.8

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A	0.6 units on a scale Standard Deviation 2.3	8.8 units on a scale Standard Deviation 13.4

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D	1.4 units on a scale Standard Deviation 3.5	8.8 units on a scale Standard Deviation 13.9

PRIMARY outcome

Timeframe: 1 hour post settling

Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A	1.2 units on a scale Standard Deviation 3.2	13 units on a scale Standard Deviation 18.7

PRIMARY outcome

Timeframe: 1 hour post settling

Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A	-0.041 LogMAR Standard Deviation 0.049	-0.035 LogMAR Standard Deviation 0.055

PRIMARY outcome

Timeframe: 1 hour post settling

Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D	-0.041 LogMAR Standard Deviation 0.049	-0.040 LogMAR Standard Deviation 0.049

PRIMARY outcome

Timeframe: 1 hour post settling

Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)

Outcome measures

Measure	Enfilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.	Omafilcon A n=60 Participants Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A	-0.041 LogMAR Standard Deviation 0.049	-0.043 LogMAR Standard Deviation 0.050

Adverse Events

Enfilcon A / Omafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enfilcon A / Ocufilcon D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enfilcon A / Methafilcon 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

Dr. Robert Montés-Mico O.D., MPhil, PhD

Optics Department, University of Valencia 46100 Valencia, Spain

Phone: 34-9635-44764

Email: robert.montes@uv.es

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
• Publication restrictions are in place

Restriction type: OTHER