Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

NCT02676258 | Completed

• 1 other identifier: 1030313M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

silicone hydrogel daily disposable soft contact lens

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  logMAR visual acuity (VA) over all visits.

  over all follow-up visits for 3 month study period

Secondary Outcomes (2)

• Any Slit Lamp Finding > Grade 2

  over all follow-up visits for the 3 month study period

• Subjective Response to Comfort, symptoms and complaints

  over all follow-up visits for the 3 month study period

Study Arms (2)

Si-Hy soft contact lens

EXPERIMENTAL

olifilon B daily disposable soft contact lens

Device: Si-Hy (olifilcon B)

Vistakon soft contact lens

ACTIVE COMPARATOR

narafilcon A daily disposable soft contact lens

Device: Vistakon (narafilcon A)

Interventions

Si-Hy (olifilcon B) DEVICE

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

Si-Hy soft contact lens

Vistakon (narafilcon A) DEVICE

Wear Vistakon soft contact lens for 3 months

Vistakon soft contact lens

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visco Vision Inc.: lead

Study Sites (1)

MayKay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Huey Chuan Cheng, MD MS

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2016
• First Posted: February 8, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)