Myopia
Conditions
Brief summary
The objective of this investigation is to compare the visual clinical performance of two daily disposable soft contact lenses.
Detailed description
This is a prospective, multiple day, double (investigator and subject) masked, randomized, bilateral crossover study comparing a Test lens against an appropriate Control lens. Main aim is to compare visual acuity and subjective vision ratings of vision quality between two lenses in habitual soft lens wearers.
Interventions
Daily disposable, soft contact lenses worn for one week.
Daily disposable, soft contact lenses worn for one week.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Are 8 to 18 years of age (inclusively) * Have read, signed and dated: * Age 18 - The Participant Informed Consent Form (participant only) * Age 12-17 - The Parental Permission Form (participant and parent) * Age 8-11 - The Parental Permission Form (parent) and Assent form (participant) * Are willing and able to follow instructions and maintain the appointment schedule. * Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye, including myopia control soft contact lenses as below- * Currently wears spherical soft contact lenses or myopia control soft contact lenses. * Have a pair of wearable back-up spectacles. * Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study. * Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D * Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction. * Have clear corneas with no corneal scars or any active ocular disease. * Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit. * Demonstrate an acceptable fit with the study contact lenses. * Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit.
Exclusion criteria
* Have taken part in another clinical research study within the last 14 days. * Are currently habitual wearers of toric contact lenses. * Have worn any rigid contact lenses or ortho-keratology contact lenses in the past 30 days. * Are an extended contact lens wearer (i.e., sleeping with their contact lenses). * Are on ongoing atropine treatment for myopia control. * Have a difference of \> 1.0 D in best vision sphere subjective refraction between eyes. * Have amblyopia and/or strabismus/binocular vision problem. * Have any known active ocular disease, allergies and/or infection. * Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. * Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. * Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study. * Have undergone refractive error surgery or intraocular surgery. * Are a member of CORL directly involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast, Binocular, Distance Visual Acuity (logMAR) | At the end of one week wear | High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Vision Quality | At the end of one week wear | Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good) |
Countries
United States
Participant flow
Pre-assignment details
Ten participants were enrolled in the study. One participant was excluded due to screening failure. (n=9)
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total eight participants were analyzed who completed all study visits. (One participant was excluded from the analysis due to protocol deviation) | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 8 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 1 / 9 | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
High Contrast, Binocular, Distance Visual Acuity (logMAR)
High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.
Time frame: At the end of one week wear
Population: Analysis population includes all the participants who completed all the study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lenses (Stenfilcon A) | High Contrast, Binocular, Distance Visual Acuity (logMAR) | -0.15 logMAR | Standard Deviation 0.03 |
| Control Lenses (Omafilcon A) | High Contrast, Binocular, Distance Visual Acuity (logMAR) | -0.15 logMAR | Standard Deviation 0.05 |
Secondary
Subjective Vision Quality
Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good)
Time frame: At the end of one week wear
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lenses (Stenfilcon A) | Subjective Vision Quality | 94.12 units on a scale | Standard Deviation 4.67 |
| Control Lenses (Omafilcon A) | Subjective Vision Quality | 87.12 units on a scale | Standard Deviation 11.61 |