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Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

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ClinicalTrials.gov Identifier: NCT02676258
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myopia Device: Si-Hy (olifilcon B) Device: Vistakon (narafilcon A) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
Study Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: over all follow-up visits for 3 month study period ]
    logMAR visual acuity (VA) over all visits.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676258


Locations
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Taiwan
MayKay Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Visco Vision Inc.
Investigators
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Principal Investigator: Huey Chuan Cheng, MD MS Mackay Memorial Hospital

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Responsible Party: Visco Vision Inc.
ClinicalTrials.gov Identifier: NCT02676258     History of Changes
Other Study ID Numbers: 1030313M
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Visco Vision Inc.:
silicone hydrogel daily disposable soft contact lens
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases