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Completed

NCT Number: NCT02801006

The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kodama Eye Clinic, Terada, Kyoto, Japan

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About this study

This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 years of age and 42 years of age.
  • Soft contact lens wearers who are not required to have Presbyopic correction.
  • Soft contact lens wearers without trouble.
  • Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
  • Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
  • Can achieve a corrected visual acuity of 1.0 or better.
  • Can read and understand the study information document, and sign the participation consent form.
  • Can visit the clinic at designated examination visits.
  • Has received periodical examinations at an eye clinic within the past two years.

Exclusion criteria

A person will be excluded from the study if he/she:

  • Has a systemic disease that may affect the ocular health.
  • Is pregnant or lactating.
  • Has received a systemic or local medication that may affect this study.
  • Has an infectious eye disease.
  • Has eye and systemic active allergic diseases that interferes with SCL wear.
  • Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
  • Has a history of hard contact lens wear within 30 days.
  • Is currently participating in another clinical research study.
  • Has undergone refractive surgery.

Treatment and study plan

stenfilcon A

Device

contact lens

etafilcon A

Device

contact lens

Primary outcomes

  1. Comfort

    Time frame: 2 weeks

    Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all

  2. Dryness

    Time frame: 2 weeks

    Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all

  3. Clarity of Vision

    Time frame: 2 weeks

    Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all

  4. Stability of Vision

    Time frame: 2 weeks

    Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision

  5. Lens Handling

    Time frame: 2 weeks

    Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all

  6. Overall Satisfaction

    Time frame: 2 weeks

    Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2016
Registry last updated
Jan 9, 2018

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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