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Completed

NCT Number: NCT02366910

Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

About this study

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

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 read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
  • Is able to wear lenses for at least 12 hours a day.

Exclusion criteria

  • Is participating in any concurrent clinical 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;
  • Has undergone refractive error surgery;
  • *For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Treatment and study plan

omafilcon A

Device

Each subject randomized to wear either the test or control in either the left of right eye.

delefilcon A

Device

Each subject randomized to wear either the test or control in either the left of right eye.

Primary outcomes

  1. Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A

    Time frame: 12 Hours of Wear

    Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

  2. Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A

    Time frame: 12 Hours of Wear

    Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

  3. Moisture Retention (Mean) of Omafilcon A and Delefilcon A

    Time frame: 12 Hours

    Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

  4. Moisture Retention (Median) of Omafilcon A and Delefilcon A

    Time frame: 12 Hours

    Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2015
Registry last updated
Jul 31, 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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