Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Si-Hy (olifilcon B); Device: Vistakon (narafilcon A)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • MayKay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Si-Hy soft contact lens; olifilon B daily disposable soft contact lens	Device: Si-Hy (olifilcon B); Wear Si-Hy silicone hydrgel soft contact lens for 3 months
Active Comparator: Vistakon soft contact lens; narafilcon A daily disposable soft contact lens	Device: Vistakon (narafilcon A); Wear Vistakon soft contact lens for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	logMAR visual acuity (VA) over all visits.	over all follow-up visits for 3 month study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Slit Lamp Finding > Grade 2	All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.	over all follow-up visits for the 3 month study period
Subjective Response to Comfort, symptoms and complaints	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.	over all follow-up visits for the 3 month study period

Collaborators and Investigators

• Sponsor: Visco Vision Inc.
• Investigators: Principal Investigator: Huey Chuan Cheng, MD MS, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 30, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: silicone hydrogel daily disposable soft contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 1030313M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No