Myopia
Conditions
Brief summary
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
Detailed description
The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing myopic soft lens wearers.
Interventions
DEVICELens 1 (ocufilcon D)
15 minutes of daily wear
DEVICELens 2 (somofilcon A)
15 minutes of daily wear
Sponsors
CooperVision, Inc.
Centre for Ocular Research & Education, Canada
Study design
Allocation
NON_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
1. Are at least 18 years of age and have full legal capacity to volunteer; 2. Have understood and signed an information consent letter; 3. Are willing and able to maintain the appointment schedule; 4. Are an adapted soft contact lens wearer; 5. Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye; 6. Have a refraction with a cylinder component of no more than -1.00DC in each eye; 7. Can be fitted with and achieve a distance visual acuity of +0.10 logMAR or better in each eye with the study contact lenses.
Exclusion criteria
1. Are participating in any concurrent clinical or research study; 2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use; 3. Have a systemic condition that would contraindicate contact lens use; 4. Are using any systemic or topical medications that would contraindicate contact lens use; 5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study; 6. Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort | Immediately after lens application | The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best). |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORLyndon Jones, PhD FCOptom
Centre for Ocular Research and Education
Participant flow
Pre-assignment details
Forty Five participants were screened. All the participants who were eligible in the study were included in the analysis. (n=45)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.0 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
None listed