Ametropia, 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 soft lens wearers.
Interventions
DEVICEControl Lens (omafilcon A)
15 minutes of daily wear
DEVICETest Lens (stenfilcon A)
15 minutes of daily wear
Sponsors
CooperVision International Limited (CVIL)
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 capacity to consent; 2. Have understood and signed an information consent form; 3. Are an adapted soft contact lens wearer (worn for at least 3 months); 4. Have a contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye; 5. Have a refraction with a cylinder component of no more than -0.75DC in each eye; 6. Can achieve a best spectacle-corrected visual acuity in each eye of +0.10 logMAR or better.
Exclusion criteria
1. Participation in a contact lens or contact lens care product clinical trial in the previous 30 days; 2. Have any known active anterior segment disease and/or infection or slit lamp findings that would contraindicate contact lens wear; 3. Have a systemic condition that would contraindicate contact lens wear; 4. Are using any systemic or topical medications that would contraindicate contact lens wear; 5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study; 6. Are an employee of the study site (Centre for Ocular Research \& Education) and directly involved in the study (ie. on the delegation log).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort Rating | At the end of 15 minutes of daily wear | The primary outcome of this study is lens comfort on a scale of 0-100 (0= worst, 100=best). |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJill Woods, MSc, MCOptom
Centre of Ocular Research and Education
Outcome results
None listed