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OpenTrials
Completed

NCT Number: NCT03454542

Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses

A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo

Waterloo, Ontario, Canada

About this study

The objectives of the study are

  • to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and
  • to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 18 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is of Caucasian heritage;
  • Habitually wears soft spherical daily disposable contact lenses with a power between

-0.50 to -2.75D (inclusive);

  • Demonstrates an acceptable fit with both study CL designs (initial & modified);
  • Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;
  • Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;
  • Should own a wearable pair of spectacles. -

Exclusion criteria

  • Is participating in any concurrent clinical or research study;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
  • Is aphakic;
  • Has undergone refractive error surgery; -

Treatment and study plan

Menicon Modified Lens Design

Device

Randomized in a daily wear, single day (6 hours or more) evaluation

Primary outcomes

  1. Participant's subjective rating of comfort, Questionnaire

    Time frame: 2 Days

    Participants rate their eye comfort by subjective questionnaire (non-annotated scale, 0-100, 0=painful, 100=can't feel the lenses)

  2. Participant's subjective rating of vision, Questionnaire

    Time frame: 2 Days

    Participants rate their vision by subjective questionnaire (non-annotated scale, 0-100, 0=not at all sharp/clear, 100=sharp/clear

  3. Participant's subjective rating of lens handling, Questionnaire

    Time frame: 2 Days

    Participants rate their ability to handle the contact lens by subjective questionnaire (non-annotated scale, 0-100, 0=very difficult, 100=very easy

Sponsors and collaborators

Lead sponsor

Menicon Co., Ltd.

Industry

Registry information

Official study title

Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)

Acronym: BASS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2018
Registry last updated
Oct 5, 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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