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OpenTrials
Completed

NCT Number: NCT03779503

Comparison of Two Daily Disposable Soft Contact Lenses

The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CooperVision Inc.

Pleasanton, California, 94588, United States

About this study

This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • They are between 18 and 40 years of age (inclusive).
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
  • They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
  • They own a wearable pair of spectacles and wear them on the day of the initial visit.
  • At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  • They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
  • They agree not to participate in other clinical research for the duration of the study.

Exclusion criteria

  • They have an ocular disorder, which would normally contra-indicate contact lens wear.
  • They have a systemic disorder, which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or breastfeeding.
  • They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
  • They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  • They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Treatment and study plan

midafilcon A

Device

midafilcon A 1 day daily disposable contact lens

somofilcon A

Device

somofilcon A 1 day daily disposable contact lens

Primary outcomes

  1. Lens Fit - Horizontal Centration

    Time frame: Baseline

    Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)

  2. Lens Fit - Horizontal Centration

    Time frame: One Week

    Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)

  3. Lens Fit - Vertical Centration

    Time frame: Baseline

    Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)

  4. Lens Fit - Vertical Centration

    Time frame: One Week

    Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)

  5. Lens Fit - Corneal Coverage

    Time frame: Baseline

    Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)

  6. Lens Fit - Corneal Coverage

    Time frame: One Week

    Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)

  7. Lens Fit - Lens Movement

    Time frame: Baseline

    Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)

  8. Lens Fit - Lens Movement

    Time frame: One Week

    Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)

Secondary outcomes

  1. Subjective Score for Vision

    Time frame: Baseline

    Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)

  2. Subjective Score for Vision

    Time frame: One week

    Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Oct 8, 2020

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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