Astigmatism Bilateral
Conditions
Brief summary
The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
Detailed description
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.
Interventions
DEVICEmidafilcon A
midafilcon A 1 day daily disposable contact lens
DEVICEsomofilcon A
somofilcon A 1 day daily disposable contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. They are between 18 and 40 years of age (inclusive). 2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes. 5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction. 6. They own a wearable pair of spectacles and wear them on the day of the initial visit. 7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. 8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). 9. They agree not to participate in other clinical research for the duration of the study.
Exclusion criteria
1. They have an ocular disorder, which would normally contra-indicate contact lens wear. 2. They have a systemic disorder, which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study. 4. They are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or breastfeeding. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear 9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. 10. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit - Lens Movement | Baseline | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) |
| Lens Fit - Corneal Coverage | Baseline | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) |
| Lens Fit - Horizontal Centration | Baseline | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) |
| Lens Fit - Vertical Centration | Baseline | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Score for Vision | Baseline | Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear either midafilcon A 1 day or somofilcon A 1 day for one week of daily wear the cross-over to the other for one week of daily wear during the study.
midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 1 |
| First Intervention | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 55 Participants | — |
| Age, Continuous | 26.3 years STANDARD_DEVIATION 6.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 55 participants | — |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Corneal Coverage | Slightly inadequate | 17 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Slightly excessive | 7 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Optimum | 76 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Extremely excessive | 0 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Extremely excessive | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Slightly inadequate | 22 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Optimum | 70 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Slightly excessive | 7 percentage of lenses |
Primary
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time frame: One Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Corneal Coverage | Slightly inadequate | 19 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Slightly excessive | 8 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Optimum | 72 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Extremely excessive | 0 percentage of lenses |
| Midafilcon A | Lens Fit - Corneal Coverage | Extremely inadequate | 2 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Extremely excessive | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Slightly inadequate | 34 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Optimum | 60 percentage of lenses |
| Somofilcon A | Lens Fit - Corneal Coverage | Slightly excessive | 6 percentage of lenses |
Primary
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Time frame: One Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Horizontal Centration | Extremely Temporal | 0 participants of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Slightly nasal | 8 participants of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Slightly Temporal | 32 participants of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Optimum | 60 participants of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Extremely nasal | 0 participants of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Optimum | 55 participants of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Extremely Temporal | 0 participants of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Extremely nasal | 0 participants of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Slightly nasal | 6 participants of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Slightly Temporal | 40 participants of lenses |
Primary
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Horizontal Centration | Slightly nasal | 6 percentage of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Slightly Temporal | 33 percentage of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Optimum | 61 percentage of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Extremely Temporal | 0 percentage of lenses |
| Midafilcon A | Lens Fit - Horizontal Centration | Extremely nasal | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Extremely Temporal | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Extremely nasal | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Slightly nasal | 4 percentage of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Optimum | 48 percentage of lenses |
| Somofilcon A | Lens Fit - Horizontal Centration | Slightly Temporal | 48 percentage of lenses |
Primary
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Lens Movement | Slightly inadequate | 11 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Slightly excessive | 33 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Optimum | 56 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Extremely excessive | 0 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Extremely excessive | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Slightly inadequate | 9 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Optimum | 79 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Slightly excessive | 13 percentage of lenses |
Primary
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time frame: One Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Lens Movement | Slightly inadequate | 13 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Slightly excessive | 30 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Optimum | 55 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Extremely excessive | 2 percentage of lenses |
| Midafilcon A | Lens Fit - Lens Movement | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Extremely excessive | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Extremely inadequate | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Slightly inadequate | 11 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Optimum | 75 percentage of lenses |
| Somofilcon A | Lens Fit - Lens Movement | Slightly excessive | 13 percentage of lenses |
Primary
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Time frame: One Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Vertical Centration | Slightly inferior | 32 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Slightly Superior | 19 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Optimum | 47 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Extremely Superior | 0 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Extremely inferior | 2 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Extremely Superior | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Extremely inferior | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Slightly inferior | 26 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Optimum | 43 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Slightly Superior | 30 percentage of lenses |
Primary
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Midafilcon A | Lens Fit - Vertical Centration | Slightly inferior | 31 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Slightly Superior | 15 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Optimum | 54 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Extremely Superior | 0 percentage of lenses |
| Midafilcon A | Lens Fit - Vertical Centration | Extremely inferior | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Extremely Superior | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Extremely inferior | 0 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Slightly inferior | 22 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Optimum | 46 percentage of lenses |
| Somofilcon A | Lens Fit - Vertical Centration | Slightly Superior | 31 percentage of lenses |
Secondary
Subjective Score for Vision
Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Midafilcon A | Subjective Score for Vision | 93.1 units on a scale | Standard Deviation 8.5 |
| Somofilcon A | Subjective Score for Vision | 95.0 units on a scale | Standard Deviation 8.6 |
Secondary
Subjective Score for Vision
Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Midafilcon A | Subjective Score for Vision | 86.5 units on a scale | Standard Deviation 15.5 |
| Somofilcon A | Subjective Score for Vision | 91.7 units on a scale | Standard Deviation 12.2 |