Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Si-Hy (olifilcon B); Device: Vistakon (narafilcon A)

• Registration Number: NCT02676258
• Lead Sponsor: Visco Vision Inc.

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 Timeline

• Study Start: 2015-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2016-01-30
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Si-Hy soft contact lens	Si-Hy (olifilcon B)	olifilon B daily disposable soft contact lens
Vistakon soft contact lens	Vistakon (narafilcon A)	narafilcon A daily disposable soft contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	over all follow-up visits for 3 month study period	logMAR visual acuity (VA) over all visits.

Secondary Outcome Measures

Name	Time	Method
Any Slit Lamp Finding > Grade 2	over all follow-up visits for the 3 month study period	All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Subjective Response to Comfort, symptoms and complaints	over all follow-up visits for the 3 month study period	subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.

Trial Locations

Locations (1)

MayKay Memorial Hospital; 🇨🇳 Taipei, Taiwan