Myopia
Conditions
Brief summary
This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).
Detailed description
This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.
Interventions
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
* They are of aged 18-40 and have capacity to volunteer. * They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They agree not to participate in other clinical research for the duration of this study. * They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive) * They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction). * They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. * They currently use soft contact lenses or have done so in the previous six months.
Exclusion criteria
* They have an ocular disorder which would normally contra-indicate contact lens wear. * They have a systemic disorder which would normally contra-indicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They have had cataract surgery. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * They are pregnant or lactating. * They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * 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. * They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity Using logMAR | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn | Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction |
| Lens Fit - Horizontal Centration | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn | Assessment of horizontal centration of lens on eye |
| Lens Fit - Vertical Centration | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn | Assessment of vertical centration of lens on eye |
| Lens Fit - Corneal Coverage of Lens | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn | Assessment of corneal coverage of lens on eye |
| Lens Fit - Movement of Lens | Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn | Assessment of movement of lens on eye |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants were randomized to wear each of the 3 different contact lens pairs | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Intervention (1 Hour, Visit 2) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 29.0 years STANDARD_DEVIATION 6.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 40 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 | 0 / 39 |
Outcome results
Primary
Lens Fit - Corneal Coverage of Lens
Assessment of corneal coverage of lens on eye
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At dispense | Extremely inadequate | 0 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At dispense | Slightly inadequate | 6 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At dispense | Optimum | 29 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At dispense | Slightly excessive | 5 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At dispense | Extremely excessive | 0 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At follow up | Extremely inadequate | 0 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At follow up | Slightly inadequate | 5 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At follow up | Optimum | 30 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At follow up | Slightly excessive | 5 Participants |
| Omafilcon A | Lens Fit - Corneal Coverage of Lens | At follow up | Extremely excessive | 0 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At follow up | Slightly excessive | 1 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At dispense | Extremely inadequate | 0 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At follow up | Extremely inadequate | 1 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At dispense | Extremely excessive | 0 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At dispense | Slightly inadequate | 16 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At follow up | Extremely excessive | 0 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At follow up | Optimum | 24 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At dispense | Optimum | 22 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At follow up | Slightly inadequate | 13 Participants |
| Methafilcon A IV | Lens Fit - Corneal Coverage of Lens | At dispense | Slightly excessive | 1 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At follow up | Optimum | 30 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At dispense | Slightly excessive | 5 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At dispense | Extremely excessive | 0 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At follow up | Extremely inadequate | 0 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At follow up | Slightly excessive | 5 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At follow up | Slightly inadequate | 4 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At dispense | Extremely inadequate | 0 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At follow up | Extremely excessive | 0 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At dispense | Slightly inadequate | 4 Participants |
| Ocufilcon B | Lens Fit - Corneal Coverage of Lens | At dispense | Optimum | 30 Participants |
Primary
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens on eye
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Omafilcon A | Lens Fit - Horizontal Centration | At dispense | Extremely nasal | 0 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At dispense | Slightly nasal | 1 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At dispense | Optimum | 23 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At dispense | Slightly temporal | 16 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At dispense | Extremely temporal | 0 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At follow up | Extremely nasal | 0 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At follow up | Slightly nasal | 1 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At follow up | Optimum | 22 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At follow up | Slightly temporal | 17 Participants |
| Omafilcon A | Lens Fit - Horizontal Centration | At follow up | Extremely temporal | 0 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At follow up | Slightly temporal | 22 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At dispense | Extremely nasal | 0 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At follow up | Extremely nasal | 0 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At dispense | Extremely temporal | 0 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At dispense | Slightly nasal | 1 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At follow up | Extremely temporal | 1 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At follow up | Optimum | 14 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At dispense | Optimum | 17 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At follow up | Slightly nasal | 2 Participants |
| Methafilcon A IV | Lens Fit - Horizontal Centration | At dispense | Slightly temporal | 21 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At follow up | Optimum | 26 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At dispense | Slightly temporal | 12 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At dispense | Extremely temporal | 0 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At follow up | Extremely nasal | 0 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At follow up | Slightly temporal | 13 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At follow up | Slightly nasal | 0 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At dispense | Extremely nasal | 0 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At follow up | Extremely temporal | 0 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At dispense | Slightly nasal | 1 Participants |
| Ocufilcon B | Lens Fit - Horizontal Centration | At dispense | Optimum | 26 Participants |
Primary
Lens Fit - Movement of Lens
Assessment of movement of lens on eye
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Omafilcon A | Lens Fit - Movement of Lens | At follow up | Extremely inadequate | 0 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At dispense | Slightly inadequate | 1 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At follow up | Slightly inadequate | 2 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At follow up | Optimum | 23 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At follow up | Extremely excessive | 0 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At follow up | Slightly excessive | 15 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At dispense | Optimum | 24 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At dispense | Extremely inadequate | 0 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At dispense | Slightly excessive | 15 Participants |
| Omafilcon A | Lens Fit - Movement of Lens | At dispense | Extremely excessive | 0 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At follow up | Extremely inadequate | 0 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At dispense | Optimum | 25 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At dispense | Extremely excessive | 0 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At follow up | Slightly inadequate | 2 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At dispense | Slightly inadequate | 7 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At follow up | Extremely excessive | 0 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At follow up | Optimum | 28 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At dispense | Slightly excessive | 7 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At dispense | Extremely inadequate | 0 Participants |
| Methafilcon A IV | Lens Fit - Movement of Lens | At follow up | Slightly excessive | 9 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At dispense | Slightly excessive | 15 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At follow up | Extremely excessive | 0 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At dispense | Extremely inadequate | 0 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At dispense | Slightly inadequate | 8 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At dispense | Optimum | 16 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At follow up | Slightly excessive | 19 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At dispense | Extremely excessive | 0 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At follow up | Extremely inadequate | 0 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At follow up | Slightly inadequate | 1 Participants |
| Ocufilcon B | Lens Fit - Movement of Lens | At follow up | Optimum | 19 Participants |
Primary
Lens Fit - Vertical Centration
Assessment of vertical centration of lens on eye
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Omafilcon A | Lens Fit - Vertical Centration | At dispense | Extremely inferior | 0 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At dispense | Slightly inferior | 12 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At dispense | Optimum | 20 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At dispense | Slightly superior | 8 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At dispense | Extremely superior | 0 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At follow up | Extremely inferior | 0 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At follow up | Slightly inferior | 15 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At follow up | Optimum | 18 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At follow up | Slightly superior | 7 Participants |
| Omafilcon A | Lens Fit - Vertical Centration | At follow up | Extremely superior | 0 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At follow up | Slightly superior | 21 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At dispense | Extremely inferior | 0 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At follow up | Extremely inferior | 0 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At dispense | Extremely superior | 0 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At dispense | Slightly inferior | 6 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At follow up | Extremely superior | 0 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At follow up | Optimum | 14 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At dispense | Optimum | 9 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At follow up | Slightly inferior | 4 Participants |
| Methafilcon A IV | Lens Fit - Vertical Centration | At dispense | Slightly superior | 24 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At follow up | Optimum | 26 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At dispense | Slightly superior | 3 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At dispense | Extremely superior | 0 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At follow up | Extremely inferior | 0 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At follow up | Slightly superior | 2 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At follow up | Slightly inferior | 11 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At dispense | Extremely inferior | 0 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At follow up | Extremely superior | 0 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At dispense | Slightly inferior | 9 Participants |
| Ocufilcon B | Lens Fit - Vertical Centration | At dispense | Optimum | 27 Participants |
Primary
Visual Acuity Using logMAR
Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Visual Acuity Using logMAR | At Dispense | -0.14 logMAR | Standard Deviation 0.09 |
| Omafilcon A | Visual Acuity Using logMAR | Follow Up | -0.14 logMAR | Standard Deviation 0.07 |
| Methafilcon A IV | Visual Acuity Using logMAR | At Dispense | -0.13 logMAR | Standard Deviation 0.07 |
| Methafilcon A IV | Visual Acuity Using logMAR | Follow Up | -0.14 logMAR | Standard Deviation 0.07 |
| Ocufilcon B | Visual Acuity Using logMAR | Follow Up | -0.14 logMAR | Standard Deviation 0.07 |
| Ocufilcon B | Visual Acuity Using logMAR | At Dispense | -0.13 logMAR | Standard Deviation 0.07 |