the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

Visco Vision

Status

Completed

Conditions

Myopia

Treatments

Device: oxysoft (olifilcon C)

Device: Si-Hy (olifilcon B)

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03934788

1060510M

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.