Ametropia
Conditions
Brief summary
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
Detailed description
The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) 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
No
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 the required time of the study. * Is willing and able to follow instructions and maintain the appointment schedule. * Has refractive astigmatism no higher than -0.75 DC. * Can be fit with the available lens parameters (sphere +8.00 to -10.00D). * Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
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 | 15 minutes | Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all study participants. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 9.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 33 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 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
Primary
Lens Fit Acceptance
Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.
Time frame: 15 minutes
Population: All participants wore Lens A and Lens B in sequential order.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Lens Fit Acceptance | 3.51 score on a scale | Standard Deviation 0.9 |
| Lens B | Lens Fit Acceptance | 3.68 score on a scale | Standard Deviation 0.7 |