the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
- Conditions
- Myopia
- Interventions
- Device: Si-Hy (olifilcon B)Device: oxysoft (olifilcon C)
- Registration Number
- NCT03934788
- Lead Sponsor
- Visco Vision Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SiHy Si-Hy (olifilcon B) olifilcon B, dialy disposable soft contact lens, 1 month Oxysoft oxysoft (olifilcon C) olifilcon C, daily disposable soft contact lens, 1 month
- Primary Outcome Measures
Name Time Method Log MAR visual acuities 1 month The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
- Secondary Outcome Measures
Name Time Method slit lamp findings 1 month Any slit lamp findings \> grade 2 \[ Time Frame: over all follow-up visits for the 1 month \] slit lamp findings on all dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Trial Locations
- Locations (3)
Tri-Service General Hospital_Tingjhou
🇨🇳Taipei, Taiwan
MayKay Memorial Hospital
🇨🇳Taipei, Taiwan
Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation
🇨🇳New Taipei City, Taiwan