Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

NCT ID: NCT02676258

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-11-30

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Si-Hy soft contact lens

olifilon B daily disposable soft contact lens

Group Type: EXPERIMENTAL

Si-Hy (olifilcon B)

Intervention Type: DEVICE

Wear Si-Hy silicone hydrgel soft contact lens for 3 months

Vistakon soft contact lens

narafilcon A daily disposable soft contact lens

Group Type: ACTIVE_COMPARATOR

Vistakon (narafilcon A)

Intervention Type: DEVICE

Wear Vistakon soft contact lens for 3 months

Interventions

Si-Hy (olifilcon B)

Wear Si-Hy silicone hydrgel soft contact lens for 3 months

Intervention Type: DEVICE

Vistakon (narafilcon A)

Wear Vistakon soft contact lens for 3 months

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Visco Vision Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huey Chuan Cheng, MD MS

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

MayKay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

1030313M

Identifier Type: -

Identifier Source: org_study_id