Hyperopia, Myopia
Conditions
Brief summary
This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.
Detailed description
The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.
Interventions
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
All participants received Lens A and then Lens B in fixed-sequence order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is at least 18 years of age and has full legal capacity to volunteer. * Has read and signed an information consent letter. * Self-reports having a full eye examination in the previous two years. * Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week. * Is willing and able to follow instructions and maintain the appointment schedule. * Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum. * Has refractive astigmatism no higher than -0.75DC. * Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)
Exclusion criteria
* Is participating in any concurrent clinical or research study. * Has any known active ocular disease and/or infection that contraindicates contact lens wear. * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. * Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. * Has known sensitivity to the diagnostic sodium fluorescein used in the study. * Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. * Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit Acceptance Rating | 15 minutes | Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who enrolled and completed all study visits. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 24.68 years STANDARD_DEVIATION 4.57 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Lens Fit Acceptance Rating
Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.
Time frame: 15 minutes
Population: All participants received Lens A and Lens B in sequential order.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Lens Fit Acceptance Rating | 3.28 score on a scale | Standard Deviation 0.6 |
| Lens B | Lens Fit Acceptance Rating | 3.48 score on a scale | Standard Deviation 0.6 |