Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).
Detailed description
This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.
Interventions
DEVICEetafilcon A
contact lens
DEVICEmethafilcon A - Interozzo
contact lens
DEVICEmethafilcon A - CVI (CooperVision)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent * Existing soft contact lens wearers or previous experience of contact lens wear * Being able to wear the study lenses for at least eight hours a day * At least 6/9 visual acuity in each eye with the study lenses * Astigmatism less than 1.50 D (Diopter) in both eyes * Agreed to follow the protocol and not to participate in other clinical research for the duration of this study
Exclusion criteria
* Have an ocular disorder which would normally contraindicate contact lens wear * Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear * Have previously had any ocular surgery such as corneal refractive surgery * Have less than 6/9 visual acuity in each eye with the study lenses * Are currently using any topical medication such as eye drops or ointment * Have any corneal distortion resulting from previous rigid lens wear or have keratoconus * Are currently pregnant or lactating * No previous contact lens wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 1 week per intervention | Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants wore enfilcon A, methafilcon A (Interozzo) and methafilcon A (CooperVision) contact lenses. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Week 1 | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Week 2 | Lost to Follow-up | 1 | 0 | 0 | 1 | 1 | 0 |
| Week 3 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 22.3 years STANDARD_DEVIATION 1.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment South Korea | 60 Participants | — |
| Sex: Female, Male Female | 60 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 0 / 54 | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 | 0 / 54 |
Outcome results
Primary
Comfort
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Time frame: 1 week per intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Comfort | 64.19 units on a scale | Standard Deviation 21.7 |
| Methafilcon A - Interozzo | Comfort | 58.57 units on a scale | Standard Deviation 22.48 |
| Methafilcon A - CVI | Comfort | 59.31 units on a scale | Standard Deviation 21.53 |