Myopia
Conditions
Keywords
myopia progression, myopia control
Brief summary
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Detailed description
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Interventions
Sponsors
Visioncare Research Ltd.
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Be between 8 and 12 years of age inclusive. * Best-corrected visual acuity by manifest refraction of +0.10 logMAR. * Spherical Equivalent Refractive Error between -0.75 and -4.00 D * inclusive astigmatism: \< -0.75 D and anisometropia: \< 1.00 D * Possess wearable and visually functional eyeglasses. * Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.
Exclusion criteria
* Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses. * Subject is currently or within 30 days prior to this study has been an active participant in another clinical study. * Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment. * Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents. * Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state. * A known allergy to fluorescein, benoxinate, proparacaine or tropicamide. * Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. * Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Refractive Error Relative to Baseline | 12 months | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline. |
| Change in Axial Length Relative to Baseline | 12 months | Mean change in axial length measurement, in millimeters at 12 months, relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Baseline | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). |
| Number of Participants With Biomicroscopic Findings | 24 months | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). |
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | 36 months | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). |
| Incidence of Adverse Events | 12 months | Cumulative incidence of adverse events. |
Countries
Canada, Portugal, Singapore, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens | 70 |
| Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Single Vision Soft Contact Lens | 74 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Months Follow-up | Lost to Follow-up | 3 | 3 |
| 12 Months Follow-up | Withdrawal by Subject | 4 | 7 |
| 24 Months Follow-up | Lost to Follow-up | 3 | 0 |
| 36 Months Follow-up | Physician Decision | 1 | 0 |
| 36 Months Follow-up | Withdrawal by Subject | 2 | 4 |
| Baseline | Physician Decision | 5 | 4 |
Baseline characteristics
| Characteristic | Total | Dual Focus Soft Contact Lens | Single Vision Soft Contact Lens |
|---|---|---|---|
| Age, Categorical <=18 years | 144 Participants | 70 Participants | 74 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.1 years STANDARD_DEVIATION 1.3 | 10.1 years STANDARD_DEVIATION 1.3 | 10.1 years STANDARD_DEVIATION 1.4 |
| Race/Ethnicity, Customized Caucasian | 79 Participants | 39 Participants | 40 Participants |
| Race/Ethnicity, Customized East Asian | 34 Participants | 16 Participants | 18 Participants |
| Race/Ethnicity, Customized Indian/Pakistani/Sri Lankan | 12 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Mixed | 13 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Canada | 64 Participants | 32 Participants | 32 Participants |
| Region of Enrollment Portugal | 21 Participants | 10 Participants | 11 Participants |
| Region of Enrollment Singapore | 31 Participants | 15 Participants | 16 Participants |
| Region of Enrollment United Kingdom | 28 Participants | 13 Participants | 15 Participants |
| Sex: Female, Male Female | 69 Participants | 32 Participants | 37 Participants |
| Sex: Female, Male Male | 75 Participants | 38 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 74 |
| other Total, other adverse events | 0 / 70 | 0 / 74 |
| serious Total, serious adverse events | 0 / 70 | 0 / 74 |
Outcome results
Primary
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Change in Axial Length Relative to Baseline | 0.09 mm | Standard Deviation 0.13 |
| Single Vision Soft Contact Lens | Change in Axial Length Relative to Baseline | 0.24 mm | Standard Deviation 0.15 |
Primary
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Change in Axial Length Relative to Baseline | 0.21 mm | Standard Deviation 0.22 |
| Single Vision Soft Contact Lens | Change in Axial Length Relative to Baseline | 0.45 mm | Standard Deviation 0.23 |
Primary
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Change in Axial Length Relative to Baseline | 0.30 mm | Standard Deviation 0.28 |
| Single Vision Soft Contact Lens | Change in Axial Length Relative to Baseline | 0.62 mm | Standard Deviation 0.3 |
Primary
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Change in Refractive Error Relative to Baseline | -0.18 Diopters | Standard Deviation 0.39 |
| Single Vision Soft Contact Lens | Change in Refractive Error Relative to Baseline | -0.58 Diopters | Standard Deviation 0.41 |
Primary
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Change in Refractive Error Relative to Baseline | -0.38 Diopters | Standard Deviation 0.52 |
| Single Vision Soft Contact Lens | Change in Refractive Error Relative to Baseline | -0.92 Diopters | Standard Deviation 0.53 |
Primary
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Change in Refractive Error Relative to Baseline | -0.51 Diopters | Standard Deviation 0.64 |
| Single Vision Soft Contact Lens | Change in Refractive Error Relative to Baseline | -1.24 Diopters | Standard Deviation 0.61 |
Secondary
Incidence of Adverse Events
Cumulative incidence of adverse events.
Time frame: 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Conjuctivitis - Not device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Not device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant infiltrative event-no device relat | 1 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Corneal event- device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Significant Adverse Events | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Corneal event- device related | 1 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Conjuctivitis - Not device related | 1 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant infiltrative event-no device relat | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Device related | 1 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Significant Adverse Events | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Not device related | 1 participants |
Secondary
Incidence of Adverse Events
Cumulative incidence of adverse events.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Meibomianitis - Not device related | 2 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Significant adverse events | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant infiltrative event- device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Blepharitis - not device related | 2 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Localized allergic reaction - device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Localized allergic reaction-not device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant-Other-Device related | 2 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant-Other- Not device related | 3 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Foreign Body -Device related | 1 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Corneal event -Device related | 3 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Corneal event- Not device related | 1 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Corneal event- Not device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant-Other-Device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Significant adverse events | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Corneal event -Device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant infiltrative event- device related | 2 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant-Other- Not device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Blepharitis - not device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Meibomianitis - Not device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Localized allergic reaction - device related | 1 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Foreign Body -Device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Localized allergic reaction-not device related | 1 participants |
Secondary
Incidence of Adverse Events
Cumulative incidence of adverse events.
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Device related | 1 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant infiltrative event Device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Not device related | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Significant Adverse Events | 0 participants |
| Dual Focus Soft Contact Lens | Incidence of Adverse Events | Conjuctivitis - Not device related | 2 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Significant Adverse Events | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Conjuctivitis - Not device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Device related | 0 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant Other - Not device related | 3 participants |
| Single Vision Soft Contact Lens | Incidence of Adverse Events | Non-significant infiltrative event Device related | 1 participants |
Secondary
Number of Participants With Biomicroscopic Findings
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Corneal Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Conjuctival Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Bulbar Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Limbal Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Palpebral Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Palpebral Roughness | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Vascularization | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Corneal Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Palpebral Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Conjuctival Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Vascularization | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Bulbar Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Palpebral Roughness | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings | Limbal Hyperemia | 0 participants |
Secondary
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Corneal Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Roughness | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Bulbar Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Vascularization | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Conjuctival Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Other Findings | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Limbal Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Corneal Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Conjuctival Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Bulbar Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Roughness | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Vascularization | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Limbal Hyperemia | 0 participants |
Secondary
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Corneal Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Conjuctival Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Bulbar Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Limbal Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Roughness | 1 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Vascularization | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Corneal Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Conjuctival Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Vascularization | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Bulbar Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Palpebral Roughness | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Limbal Hyperemia | 0 participants |
Secondary
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Corneal Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Conjuctival Staining | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Bulbar Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Limbal Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Palpebral Hyperemia | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Palpebral Roughness | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Vascularization | 0 participants |
| Dual Focus Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Other Findings | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Corneal Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Palpebral Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Conjuctival Staining | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Vascularization | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Bulbar Hyperemia | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Palpebral Roughness | 0 participants |
| Single Vision Soft Contact Lens | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Limbal Hyperemia | 0 participants |