Hyperopia, Myopia
Conditions
Brief summary
The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
Detailed description
This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.
Interventions
DEVICELens A (fanfilcon A)
Daily wear for one month
DEVICELens B (lotrafilcon B)
Daily wear for one month
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer; 2. Had read and signed an information consent letter; 3. Were willing and able to follow instructions and maintain the appointment schedule; 4. Self-reported having had a full eye examination in the previous two years; 5. Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; 6. Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week; 7. Habitually wore spherical soft contact lenses, for the past 3 months minimum: It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers; \- For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site; 8. Had refractive astigmatism no higher than -0.75DC in each eye; 9. Could 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
1. Were participating in any concurrent clinical or research study; 2. Had any known active ocular disease and/or infection that contraindicated contact lens wear; 3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable; 4. Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable; 5. Had known sensitivity to the diagnostic sodium fluorescein used in the study; 6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Had undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling on Removal | Day 27 | Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Study Population All participants that were dispensed intervention (Lens A or Lens B), regardless of eligibility or study completion | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: First Intervention 28-32 Days | Enrolled outside the study inclusion/exclusion criteria and was discontinued early | 1 | 1 |
| Period 1: First Intervention 28-32 Days | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Total Study Population | — |
|---|---|---|
| Age, Continuous | 28.2 years STANDARD_DEVIATION 6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 5 / 50 | 4 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Lens Handling on Removal
Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.
Time frame: Day 27
Population: Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits. Of 50 participants that completed the study, 1 was removed from the analysis due to a symptomatic adverse event at the final study visit which may have impacted the study data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Lens Handling on Removal | 84 score on a scale | Standard Deviation 21 |
| Lens B | Lens Handling on Removal | 89 score on a scale | Standard Deviation 17 |