Myopia
Conditions
Keywords
silicone hydrogel daily disposable soft contact lens
Brief summary
The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.
Detailed description
This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.
Interventions
DEVICESi-Hy (olifilcon B)
Wear Si-Hy silicone hydrgel soft contact lens for 3 months
DEVICEVistakon (narafilcon A)
Wear Vistakon soft contact lens for 3 months
Sponsors
Visco Vision Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject should have normal eyes and use no ocular medications * Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism * VA correctable to Log MAR 0.1 or better. * Willing to comply with all study procedures and be available for the duration of the study. * Provide signed and dated informed consent form.
Exclusion criteria
* Subjects have history of allergies that would contraindicate normal contact lens wear. * Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes. * Subjects have medications that would contraindicate contact lens wear. * Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month. * Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Any active participation in another clinical trial within 30 days prior to this study. * The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. * A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. * A history of papillary conjunctivitis that has interfered with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | over all follow-up visits for 3 month study period | logMAR visual acuity (VA) over all visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Slit Lamp Finding > Grade 2 | over all follow-up visits for the 3 month study period | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings. |
| Subjective Response to Comfort, symptoms and complaints | over all follow-up visits for the 3 month study period | subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. |
Countries
Taiwan
Outcome results
None listed