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OpenTrials
Completed

NCT Number: NCT02354924

Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

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 -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.

Treatment and study plan

Biofinity soft contact lens

Device

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.

Visco soft contact lens

Device

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.

Primary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Visual acuity correctable to snellen 20/25 or better

Secondary outcomes

  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

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 VISCO Soft Contact Lens on a Daily Wear Basis

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2015
Registry last updated
Apr 14, 2017

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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