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Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02131402
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : July 22, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Myopia
Interventions Device: ocufilcon D
Device: omafilcon A
Device: methafilcon A
Enrollment 60
Recruitment Details  
Pre-assignment Details There were 60 subjects enrolled and fitted with the study lenses. All sixty subjects completed the trial (i.e. no discontinuations).
Arm/Group Title Overall Participants Flow
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
25.78  (5.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
34
  56.7%
Male
26
  43.3%
1.Primary Outcome
Title Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.
Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
97  (8.2) 84  (20.2)
2.Primary Outcome
Title Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2.
Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
96  (8.9) 90  (13.7)
3.Primary Outcome
Title Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
97  (6.5) 86  (17.7)
4.Primary Outcome
Title Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (at insertion).
Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (at insertion).
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
94  (9.3) 82  (18.6)
5.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants surveyed at baseline, wearing Enfilcon A in one eye
Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
94  (8.5) 73  (17.0)
6.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A
Hide Description Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Participants surveyed at insertion.
Wearing Methafilcon A in the contra lateral eye. Participants surveyed at insertion.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
94  (9.3) 76  (18.7)
7.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
98  (4.2) 76  (16.4)
8.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling for Pair #2
Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling for Pair #2.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
96  (6.1) 83  (18.6)
9.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A
Hide Description 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).
Time Frame 1 hours post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
96  (6.7) 78  (17.7)
10.Primary Outcome
Title Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye
Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of subjects
Strong Enfilcon A 66.7 0.0
Slight Enfilcon A 16.7 0.0
No Preference 10.0 0.0
Slight Omafilcon A 0.0 6.7
Strong Omafilcon A 0.0 0.0
11.Primary Outcome
Title Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Surveyed at insertion of each lens Pair #2.
Wearing Ocufilcon D in the contralateral eye. Surveyed at insertion of each lens Pair #2.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of subjects
Strong Enfilcon A 38 0
Slight Enfilcon A 22 0
No Preference 35 0
Slight Ocufilcon D 0 5
Strong Ocufilcon D 0 0
12.Primary Outcome
Title Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Subject surveyed after insertion of each lens for Pair #3 wearing Enfilcon A in one eye
Subject surveyed after insertion of each lens for Pair #3 wearing Methafilcon A in the contralateral eye.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of eyes
Strong Enfilcon A 55.0 0.0
Slight Enfilcon A 18.3 0.0
No Preference 18.3 0.0
Slight Methafilcon A 0.0 5.0
Strong Methfilcon A 0.0 3.3
13.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of subjects
Strong Enfilcon A 67 0
Slight Enfilcon A 20 0
No preference 13 0
Slight Omafilcon A 0 0
Strong Omafilcon A 0 0
14.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling.
Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of subjects
Strong Enfilcon A 42 0
Slight Enfilcon A 18 0
No Preference 35 0
Slight Ocufilcon D 0 5
Strong Ocufilcon D 0 0
15.Primary Outcome
Title Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Wearing Enfilcon A in one eye, surveyed at 1 hour post settling.
Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: percentage of subjects
Strong Enfilcon A 53 0
Slight Enfilcon A 22 0
No Preference 18 0
Slight Methafilcon A 0 7
Strong Methafilcon A 0 0
16.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A
Hide Description 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)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
Assessed after 1 hour post settling. Post-blink movement, wearing Omafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (0) 2.0  (0)
17.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D
Hide Description 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)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye
Assessed after 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (0) 2.0  (0)
18.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A
Hide Description 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)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Assessed at 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
Assessed at 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (0) 2.0  (0)
19.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
Assessed after 1 hour post settling. Push up test, wearing Omafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
50  (1.8) 50  (1.8)
20.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
Assessed after 1 hour post settling. Push up test, wearing Ocufilcon D in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
50  (0.65) 50  (0.65)
21.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A
Hide Description 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)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Assessed at 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
Assessed at 1 hour post settling. Push up test, wearing Methafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
50  (0.91) 50  (0.65)
22.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A
Hide Description Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Assessed after 1 hour post settling wearing Enfilcon A in one eye.
Assessed after 1 hour post settling, wearing Omafilcon A in contralateral eye
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Optimum 100 100
Decentration acceptable 0 0
Decentration unacceptable 0 0
23.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D
Hide Description Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Assessed after 1 hour post settling, wearing Enfilcon A in one eye.
Assessed after 1 hour post settling, wearing Ocufilcon D in contralateral eye.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Optimum 100 100
Decentration Acceptable 0 0
Decentration Unacceptable 0 0
24.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A
Hide Description Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Assessed at 1 hour post settling, wearing Enfilcon A in one eye.
Assessed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
120 120
Measure Type: Number
Unit of Measure: percentage of eyes
Optimum 100 100
Decentration acceptable 0 0
Decentration unacceptable 0 0
25.Primary Outcome
Title Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants surveyed at baseline, wearing Enfilcon A in one eye
Participants surveyed at baseline, wearing Omafilcon A in contralateral eye
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (6.00) 18  (22.6)
26.Primary Outcome
Title Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D
Hide Description Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Surveyed after insertion at baseline, wearing Enfilcon A in one eye.
Surveyed after insertion at baseline, wearing Ocufilcon D in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (9.5) 11  (20.3)
27.Primary Outcome
Title Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A
Hide Description Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Participants surveyed at baseline, wearing Enfilcon A in one eye.
Participants surveyed at baseline, wearing Methafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (4.0) 15  (19.8)
28.Primary Outcome
Title Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A
Hide Description 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).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants surveyed after 1 hour wearing Enfilcon A in one eye.
Participants surveyed after1 hour wearing Omafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (2.3) 8.8  (13.4)
29.Primary Outcome
Title Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D
Hide Description Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
Participants surveyed at 1 hour post settling, wearing Ocufilcon D in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (3.5) 8.8  (13.9)
30.Primary Outcome
Title Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A
Hide Description Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
Participants surveyed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (3.2) 13  (18.7)
31.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A
Hide Description Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Omafilcon A
Hide Arm/Group Description:
Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.041  (0.049) -0.035  (0.055)
32.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D
Hide Description Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Ocufilcon D
Hide Arm/Group Description:
Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.041  (0.049) -0.040  (0.049)
33.Primary Outcome
Title Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A
Hide Description Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)
Time Frame 1 hour post settling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enfilcon A Methafilcon A
Hide Arm/Group Description:
Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.041  (0.049) -0.043  (0.050)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enfilcon A / Omafilcon A Enfilcon A / Ocufilcon D Enfilcon A / Methafilcon A
Hide Arm/Group Description

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: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.

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.

ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.

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.

methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.

All-Cause Mortality
Enfilcon A / Omafilcon A Enfilcon A / Ocufilcon D Enfilcon A / Methafilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Enfilcon A / Omafilcon A Enfilcon A / Ocufilcon D Enfilcon A / Methafilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enfilcon A / Omafilcon A Enfilcon A / Ocufilcon D Enfilcon A / Methafilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Montés-Mico O.D., MPhil, PhD
Organization: Optics Department, University of Valencia 46100 Valencia, Spain
Phone: 34-9635-44764
EMail: robert.montes@uv.es
Layout table for additonal information
Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02131402    
Other Study ID Numbers: EX-MKTG-47
First Submitted: April 28, 2014
First Posted: May 6, 2014
Results First Submitted: February 22, 2016
Results First Posted: July 22, 2016
Last Update Posted: April 4, 2017