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Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354924
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Visco Vision Inc.

Study Description
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Brief Summary:
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.

Condition or disease Intervention/treatment Phase
Myopia Device: Biofinity soft contact lens Device: Visco soft contact lens Not Applicable

Detailed Description:
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of VISCO Soft Contact Lens on a Daily Wear Basis
Study Start Date : June 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Visco soft contact lens
Olifilcon A, Daily wear, monthly disposable soft contact lens
 Device: Visco soft contact lens
Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Active Comparator: Biofinity soft contact lens
Comfilcon A, Daily wear, monthly disposable soft contact lens
 Device: Biofinity soft contact lens
Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 3 months ]
    Visual acuity correctable to snellen 20/25 or better


Secondary Outcome Measures :
  1. Slit Lamp Findings [ Time Frame: 3 month ]
    Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings

  2. Symptoms, Problems and Complaints and Incidence Rate [ Time Frame: 3 month ]
    Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye


Eligibility Criteria
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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 -1.25 D astigmatism
  • VA correctable to 20/25 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 solution use and/or "normal" contact lens wear.
  • Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test < 5mm/5min or other physical condition that would contraindicate contact lens wear.
  • Subjects have other active ocular or systemic disease that would contraindicate contact lens wear.
  • Subjects have medications that would contraindicate contact lens wear.
  • Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study.
  • Current drug or alcohol use or dependence that would interfere with adherence to study requirements.
  • Individuals participating in other clinical studies.
Contacts and Locations
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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): NCT02354924


Sponsors and Collaborators
Visco Vision Inc.
Investigators
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Principal Investigator: Huey Chuan Cheng, MD. MS Mackey Memorial Hospital
More Information
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Responsible Party: Visco Vision Inc.
ClinicalTrials.gov Identifier: NCT02354924    
Other Study ID Numbers: 1000601M
First Posted: February 3, 2015    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases