A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Visco Vision Inc.
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Log MAR visual acuities
Study Overview
Brief Summary
The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
Detailed Description
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.
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 eye and use no ocular medications
- •VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D
- •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, slip lamp findings greater than grade I (such as cornea or interstitial edema).
- •Subjects have medications that would contraindicate contact lens wear.
- •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.
- •Any active participation in another clinical trial within 30 days prior to this study.
- •Have had any cornea surgery.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
- •Monocular or monovision fits
- •Alcoholic or Drug Abused.
Arms & Interventions
Oxysoft
olifilcon C, daily disposable soft contact lens, 1 month
Intervention: oxysoft (olifilcon C) (Device)
SiHy
olifilcon B, dialy disposable soft contact lens, 1 month
Intervention: Si-Hy (olifilcon B) (Device)
Outcomes
Primary Outcomes
Log MAR visual acuities
Time Frame: 1 month
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
Secondary Outcomes
- slit lamp findings(1 month)