Hyperopia, Myopia
Conditions
Brief summary
The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one month.
Detailed description
This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.
Interventions
1 month
1 month
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 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Self-reports having a full eye examination in the previous two years; * Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone; * Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; * Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; * Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand; * Has refractive astigmatism no higher than -0.75DC in each eye; * Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).
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 or ocular 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 |
|---|---|---|
| Subjective Ratings on Lens Handling on Removal | Day 27 | Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult) |
Countries
United States
Participant flow
Pre-assignment details
Sixty-six participants were screened. Of the 66 that were dispensed with lenses, two were discontinued. One of the completing participants presented at the final visit wearing an unknown lens. It was decided to exclude all the data for this participant and this finding was reported as a major protocol deviation. All remaining participants who completed the study were included in the analysis (Analysis population n=63).
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total study population | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 1 |
| First Intervention | Vision with study contact lens subjectively unacceptable | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 4.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 46 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 3 / 66 | 2 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Subjective Ratings on Lens Handling on Removal
Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)
Time frame: Day 27
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Subjective Ratings on Lens Handling on Removal | 8.6 units on a scale | Standard Deviation 1.6 |
| Lens B | Subjective Ratings on Lens Handling on Removal | 8.5 units on a scale | Standard Deviation 2.2 |