Myopia
Conditions
Brief summary
The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
Detailed description
This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.
Interventions
DEVICETest Lens
Daily disposable with modified lens design for 2 days
DEVICEControl Lens
Daily disposable lens for 2 days
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 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 an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study * Has spectacle cylinder ≤1.00D in both eyes. * Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye. * Wears CLs in both eyes (monovision acceptable, but not monofit) * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination * Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.
Exclusion criteria
* Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any concomitant systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * 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 participating in any other type of eye-related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort With Lens | 2 days | Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision Quality | 2 days | Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision. |
| Overall Lens Fit Acceptance | 2 days | Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum |
| Overall Lens Handling | 2 days | Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling. |
| Anterior Ocular Health - Corneal Staining Extent | 2 days | Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=\>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All participants who were dispensed lenses and successfully completed the study | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 25.4 years STANDARD_DEVIATION 4.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 27 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 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Overall Comfort With Lens
Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Comfort With Lens | 86 score on a scale | Standard Deviation 15 |
| Control Lens | Overall Comfort With Lens | 72 score on a scale | Standard Deviation 26 |
Secondary
Anterior Ocular Health - Corneal Staining Extent
Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=\>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately.
Time frame: 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens | Anterior Ocular Health - Corneal Staining Extent | Nasal | 0.11 score on a scale | Standard Deviation 0.32 |
| Test Lens | Anterior Ocular Health - Corneal Staining Extent | Superior | 0.04 score on a scale | Standard Deviation 0.2 |
| Test Lens | Anterior Ocular Health - Corneal Staining Extent | Temporal | 0.10 score on a scale | Standard Deviation 0.3 |
| Test Lens | Anterior Ocular Health - Corneal Staining Extent | Inferior | 0.39 score on a scale | Standard Deviation 0.52 |
| Test Lens | Anterior Ocular Health - Corneal Staining Extent | Central | 0.10 score on a scale | Standard Deviation 0.3 |
| Control Lens | Anterior Ocular Health - Corneal Staining Extent | Inferior | 0.41 score on a scale | Standard Deviation 0.55 |
| Control Lens | Anterior Ocular Health - Corneal Staining Extent | Central | 0.16 score on a scale | Standard Deviation 0.44 |
| Control Lens | Anterior Ocular Health - Corneal Staining Extent | Nasal | 0.14 score on a scale | Standard Deviation 0.39 |
| Control Lens | Anterior Ocular Health - Corneal Staining Extent | Temporal | 0.13 score on a scale | Standard Deviation 0.34 |
| Control Lens | Anterior Ocular Health - Corneal Staining Extent | Superior | 0.06 score on a scale | Standard Deviation 0.23 |
Secondary
Overall Lens Fit Acceptance
Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Fit Acceptance | 3.11 score on a scale | Standard Deviation 0.66 |
| Control Lens | Overall Lens Fit Acceptance | 3.09 score on a scale | Standard Deviation 0.7 |
Secondary
Overall Lens Handling
Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling.
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Lens Handling | 88 score on a scale | Standard Deviation 15 |
| Control Lens | Overall Lens Handling | 87 score on a scale | Standard Deviation 14 |
Secondary
Overall Vision Quality
Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision.
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | Overall Vision Quality | 90 score on a scale | Standard Deviation 11 |
| Control Lens | Overall Vision Quality | 91 score on a scale | Standard Deviation 11 |