Myopia
Conditions
Brief summary
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
Detailed description
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.
Interventions
DEVICELens A (lehfilcon A lens)
Daily wear for 1 month.
DEVICELens B (comfilcon A lens)
Daily wear for 1 month.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Self-reports having had a full eye examination within the previous 2 years; 3. Has read and signed an information consent letter; 4. Is willing and able to follow instructions and maintain the appointment schedule; 5. Is a habitual wearer of frequent replacement contact lenses; 6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study; 7. Has refractive astigmatism no higher than -0.75DC in each eye; 8. Can be successfully fit with both study lens types; 9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
Exclusion criteria
1. Is participating in any concurrent clinical research study; 2. Has any known active ocular disease and/or infection; 3. Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration; 4. Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration; 5. Has known sensitivity to the diagnostic sodium fluorescein to be used in the study; 6. Is an employee of the Centre for Ocular Research & Education.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling on Lens Removal | 1 month | Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied) |
Countries
Canada
Participant flow
Pre-assignment details
There were 27 people screened and 26 were dispensed with study products. Two participants discontinued and 24 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Analysis Population Out of 26 participants, 2 of them discontinued. Therefore, overall base participants (Analysis population) are 24. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 1 |
| First Intervention | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Analysis Population | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 24 Participants | — |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 14.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 15 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 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Lens Handling on Lens Removal
Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Lens Handling on Lens Removal | 8.4 units on a scale | Standard Deviation 2.3 |
| Lens B | Lens Handling on Lens Removal | 8.9 units on a scale | Standard Deviation 1.3 |