Myopia
Conditions
Brief summary
The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.
Detailed description
The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.
Interventions
DEVICETest lens
contact lens
DEVICEControl lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (participant and investigator)
Intervention model description
This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has had a self-reported oculo-visual examination in the last two years. * Is at least 18 years of age and has full legal capacity to volunteer. * Has read and understood the information consent letter. * Is willing and able to follow instructions and maintain the appointment schedule. * Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops * Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps). * Has no more than 0.75 diopters of refractive astigmatism. * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination. * Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
Exclusion criteria
* Is presently participating in any other clinical or research study including eye related clinical or research study. * Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health. * Has any known sensitivity to fluorescein dye or products to be used in the study. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Lens Fit Impression | Baseline | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable |
| Number of Participants With Lens Centration | Baseline | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I) |
| Post Blink Movement | Baseline | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) |
| Primary Gaze Lag | baseline | Primary Gaze Lag (measured in mm at 0.1mm steps) |
| Up Gaze Lag | Baseline | Up Gaze Lag (measured in mm at 0.1mm steps) |
| Push-Up Tightness | baseline | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) |
| Overall Fit Acceptance | Baseline | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort Rating | Baseline | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 52 Participants | — |
| Age, Continuous | 27 years STANDARD_DEVIATION 6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 52 participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Number of Participants With Lens Centration
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Lens | Number of Participants With Lens Centration | Optimal | 17 Participants |
| Test Lens | Number of Participants With Lens Centration | Slightly Decentered | 34 Participants |
| Test Lens | Number of Participants With Lens Centration | Extreme Decentered | 1 Participants |
| Control Lens | Number of Participants With Lens Centration | Optimal | 12 Participants |
| Control Lens | Number of Participants With Lens Centration | Slightly Decentered | 39 Participants |
| Control Lens | Number of Participants With Lens Centration | Extreme Decentered | 1 Participants |
Primary
Number of Participants With Lens Centration
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Lens | Number of Participants With Lens Centration | Optimal | 20 Participants |
| Test Lens | Number of Participants With Lens Centration | Slightly Decentered | 31 Participants |
| Test Lens | Number of Participants With Lens Centration | Extreme Decentered | 1 Participants |
| Control Lens | Number of Participants With Lens Centration | Optimal | 16 Participants |
| Control Lens | Number of Participants With Lens Centration | Slightly Decentered | 36 Participants |
| Control Lens | Number of Participants With Lens Centration | Extreme Decentered | 0 Participants |
Primary
Number of Participants With Overall Lens Fit Impression
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Lens | Number of Participants With Overall Lens Fit Impression | Reduced Acceptable | 9 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Excessive Acceptable | 2 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Reduced Unacceptable | 0 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Excessive Unacceptable | 0 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Optimal | 41 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Excessive Unacceptable | 0 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Reduced Acceptable | 9 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Optimal | 41 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Excessive Acceptable | 1 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Reduced Unacceptable | 1 Participants |
Primary
Number of Participants With Overall Lens Fit Impression
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Lens | Number of Participants With Overall Lens Fit Impression | Reduced Acceptable | 7 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Excessive Acceptable | 2 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Optimal | 43 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Excessive Unacceptable | 0 Participants |
| Test Lens | Number of Participants With Overall Lens Fit Impression | Reduced Unacceptable | 0 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Excessive Unacceptable | 0 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Reduced Unacceptable | 0 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Reduced Acceptable | 7 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Optimal | 44 Participants |
| Control Lens | Number of Participants With Overall Lens Fit Impression | Excessive Acceptable | 1 Participants |
Primary
Overall Fit Acceptance
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Fit Acceptance | 3.12 units on a scale | Standard Deviation 0.39 |
| Control Lens | Overall Fit Acceptance | 3.08 units on a scale | Standard Deviation 0.36 |
Primary
Overall Fit Acceptance
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Fit Acceptance | 3.12 units on a scale | Standard Deviation 0.41 |
| Control Lens | Overall Fit Acceptance | 3.13 units on a scale | Standard Deviation 0.44 |
Primary
Post Blink Movement
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Post Blink Movement | 0.26 millimeters (mm) | Standard Deviation 0.12 |
| Control Lens | Post Blink Movement | 0.25 millimeters (mm) | Standard Deviation 0.12 |
Primary
Post Blink Movement
Post Blink Movement (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 | 0.25 millimeters (mm) | Standard Deviation 0.1 |
| Control Lens | Post Blink Movement | 0.26 millimeters (mm) | Standard Deviation 0.09 |
Primary
Primary Gaze Lag
Primary Gaze Lag (measured in mm at 0.1mm steps)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Primary Gaze Lag | 0.22 millimeters (mm) | Standard Deviation 0.12 |
| Control Lens | Primary Gaze Lag | 0.25 millimeters (mm) | Standard Deviation 0.16 |
Primary
Primary Gaze Lag
Primary Gaze Lag (measured in mm at 0.1mm steps)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Primary Gaze Lag | 0.23 millimeters (mm) | Standard Deviation 0.12 |
| Control Lens | Primary Gaze Lag | 0.22 millimeters (mm) | Standard Deviation 0.15 |
Primary
Push-Up Tightness
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Push-Up Tightness | 45 percentage | Standard Deviation 6 |
| Control Lens | Push-Up Tightness | 48 percentage | Standard Deviation 9 |
Primary
Push-Up Tightness
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Push-Up Tightness | 46 percentage | Standard Deviation 6 |
| Control Lens | Push-Up Tightness | 47 percentage | Standard Deviation 4 |
Primary
Up Gaze Lag
Up Gaze Lag (measured in mm at 0.1mm steps)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Up Gaze Lag | 0.28 millimeters (mm) | Standard Deviation 0.12 |
| Control Lens | Up Gaze Lag | 0.29 millimeters (mm) | Standard Deviation 0.2 |
Primary
Up Gaze Lag
Up Gaze Lag (measured in mm at 0.1mm steps)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Up Gaze Lag | 0.28 millimeters (mm) | Standard Deviation 0.1 |
| Control Lens | Up Gaze Lag | 0.31 millimeters (mm) | Standard Deviation 0.12 |
Secondary
Subjective Comfort Rating
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Subjective Comfort Rating | 9.0 units on a scale | Standard Deviation 1.2 |
| Control Lens | Subjective Comfort Rating | 9.4 units on a scale | Standard Deviation 0.9 |
Secondary
Subjective Comfort Rating
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time frame: 1-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Subjective Comfort Rating | 9.1 units on a scale | Standard Deviation 1.1 |
| Control Lens | Subjective Comfort Rating | 9.1 units on a scale | Standard Deviation 1 |