Myopia
Conditions
Brief summary
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).
Detailed description
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.
Interventions
DEVICETest Lens
Daily disposable contact lens
DEVICEControl Lens
Focus Dailies All Day Comfort contact lens (nelfilcon A)
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.
Intervention model description
This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years of age and has full legal capacity to volunteer * Has read, fully understood and signed the information consent letter * Currently wears or has previously worn soft contact lenses * Has spectacle cylinder ≤1.00D in both eyes. * Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye. * Has clear corneas and no active ocular disease * Is willing and able to follow product usage instructions and maintain the visit schedule.
Exclusion criteria
* Has never worn contact lenses before * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable * Has any known active ocular disease and/or infection * Has a monovision correction * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses * Is aphakic * Has undergone corneal refractive surgery * Is pregnant or lactating, determined by self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Lens Centration Assessed in Primary Gaze | Baseline | Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value) |
| Vertical Lens Centration Assessed in Primary Gaze | Baseline | Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value) |
| Lens Tightness Assessed by Push-up Test | Baseline | Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement) |
| Primary Gaze Lag Assessed Observing Lens Movement in Graticule | Baseline | Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) |
| Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Baseline | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) |
| Overall Lens Fit Acceptance | Baseline | Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) |
| Up Gaze Lag Assessed Observing Lens Movement in Graticule | Baseline | Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze). |
| Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | Baseline | Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear test lens in one eye and control lens in other eye for 6 hours. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 2 | 2 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 28 Participants | — |
| Age, Continuous | 29 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 28 participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Horizontal Lens Centration Assessed in Primary Gaze
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Horizontal Lens Centration Assessed in Primary Gaze | -0.13 millimeters | Standard Deviation 0.2 |
| Nelfilcon A Lens (Control) | Horizontal Lens Centration Assessed in Primary Gaze | -0.04 millimeters | Standard Deviation 0.21 |
Primary
Horizontal Lens Centration Assessed in Primary Gaze
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Time frame: 6-hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Horizontal Lens Centration Assessed in Primary Gaze | -0.15 millimeters | Standard Deviation 0.2 |
| Nelfilcon A Lens (Control) | Horizontal Lens Centration Assessed in Primary Gaze | -0.06 millimeters | Standard Deviation 0.16 |
Primary
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | 3.1 millimeters | Standard Deviation 0.3 |
| Nelfilcon A Lens (Control) | Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | 2.7 millimeters | Standard Deviation 0.3 |
Primary
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | 3.0 millimeters | Standard Deviation 0.3 |
| Nelfilcon A Lens (Control) | Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | 2.7 millimeters | Standard Deviation 0.4 |
Primary
Lens Tightness Assessed by Push-up Test
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Tightness Assessed by Push-up Test | 38 units on a scale | Standard Deviation 7 |
| Nelfilcon A Lens (Control) | Lens Tightness Assessed by Push-up Test | 41 units on a scale | Standard Deviation 6 |
Primary
Lens Tightness Assessed by Push-up Test
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Time frame: 6-hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Lens Tightness Assessed by Push-up Test | 41 units on a scale | Standard Deviation 8 |
| Nelfilcon A Lens (Control) | Lens Tightness Assessed by Push-up Test | 49 units on a scale | Standard Deviation 6 |
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Fit Acceptance | 2.7 units on a scale | Standard Deviation 0.6 |
| Nelfilcon A Lens (Control) | Overall Lens Fit Acceptance | 3.1 units on a scale | Standard Deviation 0.4 |
Primary
Overall Lens Fit Acceptance
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Fit Acceptance | 2.7 units on a scale | Standard Deviation 0.5 |
| Nelfilcon A Lens (Control) | Overall Lens Fit Acceptance | 3.0 units on a scale | Standard Deviation 0.5 |
Primary
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | 0.44 millimeters | Standard Deviation 0.14 |
| Nelfilcon A Lens (Control) | Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | 0.31 millimeters | Standard Deviation 0.11 |
Primary
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | 0.43 millimeters | Standard Deviation 0.17 |
| Nelfilcon A Lens (Control) | Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | 0.29 millimeters | Standard Deviation 0.11 |
Primary
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Primary Gaze Lag Assessed Observing Lens Movement in Graticule | 0.16 millimeters | Standard Deviation 0.06 |
| Nelfilcon A Lens (Control) | Primary Gaze Lag Assessed Observing Lens Movement in Graticule | 0.13 millimeters | Standard Deviation 0.05 |
Primary
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Primary Gaze Lag Assessed Observing Lens Movement in Graticule | 0.18 millimeters | Standard Deviation 0.08 |
| Nelfilcon A Lens (Control) | Primary Gaze Lag Assessed Observing Lens Movement in Graticule | 0.12 millimeters | Standard Deviation 0.04 |
Primary
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Up Gaze Lag Assessed Observing Lens Movement in Graticule | 0.41 millimeters | Standard Deviation 0.18 |
| Nelfilcon A Lens (Control) | Up Gaze Lag Assessed Observing Lens Movement in Graticule | 0.38 millimeters | Standard Deviation 0.16 |
Primary
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Up Gaze Lag Assessed Observing Lens Movement in Graticule | 0.34 millimeters | Standard Deviation 0.11 |
| Nelfilcon A Lens (Control) | Up Gaze Lag Assessed Observing Lens Movement in Graticule | 0.35 millimeters | Standard Deviation 0.14 |
Primary
Vertical Lens Centration Assessed in Primary Gaze
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Vertical Lens Centration Assessed in Primary Gaze | 0.17 millimeters | Standard Deviation 0.25 |
| Nelfilcon A Lens (Control) | Vertical Lens Centration Assessed in Primary Gaze | 0.06 millimeters | Standard Deviation 0.2 |
Primary
Vertical Lens Centration Assessed in Primary Gaze
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Time frame: 6-hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Vertical Lens Centration Assessed in Primary Gaze | 0.10 millimeters | Standard Deviation 0.22 |
| Nelfilcon A Lens (Control) | Vertical Lens Centration Assessed in Primary Gaze | -0.03 millimeters | Standard Deviation 0.25 |