NCT02676258CompletedNot Applicable
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Visco Vision Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Si-Hy soft contact lens
Experimental
olifilon B daily disposable soft contact lens
Intervention: Si-Hy (olifilcon B) (Device)
Vistakon soft contact lens
Active Comparator
narafilcon A daily disposable soft contact lens
Intervention: Vistakon (narafilcon A) (Device)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: over all follow-up visits for 3 month study period
logMAR visual acuity (VA) over all visits.
Secondary Outcomes
- Any Slit Lamp Finding > Grade 2(over all follow-up visits for the 3 month study period)
- Subjective Response to Comfort, symptoms and complaints(over all follow-up visits for the 3 month study period)
Investigators
Study Sites (1)
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