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OpenTrials
Completed

NCT Number: NCT02676258

Clinical Comparison of Two Daily Disposable 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MayKay Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Si-Hy (olifilcon B)

Device

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

Vistakon (narafilcon A)

Device

Wear Vistakon soft contact lens for 3 months

Primary outcomes

  1. Visual Acuity

    Time frame: over all follow-up visits for 3 month study period

    logMAR visual acuity (VA) over all visits.

Secondary outcomes

  1. Any Slit Lamp Finding > Grade 2

    Time frame: 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.

  2. Subjective Response to Comfort, symptoms and complaints

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Visco Vision Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2016
Registry last updated
Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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