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OpenTrials
Completed

NCT Number: NCT03372551

Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

About this study

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has had a self-reported oculo-visual examination in the last two years;
  • Has read, understood, and signed the information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
  • Must be able to achieve 20/30 or better (in each eye) with the study lenses;
  • Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
  • Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
  • Has no more than 0.75 diopters of refractive astigmatism;
  • Has clear corneas and no active* ocular disease;
  • Has not worn lenses for at least 12 hours before the examination.

Exclusion criteria

  • Is presently participating in any other clinical or research study including eye related clinical or research study;
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
  • Has any known sensitivity to fluorescein dye or products to be used in the study.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Treatment and study plan

somofilcon A 1 day test lens

Device

Contact lens

Other names: somofilcon A daily disposable test soft contact lens, Invigor I, Test lens

somofilcon A 1 day control lens

Device

Contact lens

Other names: somofilcon A daily disposable control soft contact lens, Select 1-Day, Control lens

Primary outcomes

  1. Comfort

    Time frame: up to 1 week

    Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)

  2. Preference

    Time frame: up to 1 week

    Overall lens that subject prefers or no preference

  3. Vision

    Time frame: Up to 1 week

    Visual acuity measured in logMAR

  4. Subjective Vision

    Time frame: up to 1 week

    Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)

  5. Corneal Staining

    Time frame: up to 1 week

    Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps

  6. Conjunctival Staining

    Time frame: up to 1 week

    Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Jul 23, 2019

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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