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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: oxysoft (olifilcon C)
* Device: Si-Hy (olifilcon B)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxysoft<br>olifilcon C, daily disposable soft contact lens, 1 month | Device: oxysoft (olifilcon C)<br>* subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.<br>|
| Active Comparator: SiHy<br>olifilcon B, dialy disposable soft contact lens, 1 month | Device: Si-Hy (olifilcon B)<br>* subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log MAR visual acuities | The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| slit lamp findings | 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens material, silicon hydrogel