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Completed

NCT Number: NCT02402127

Lubricity Post-Wear - Competitive Lenses Pilot

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must sign an informed consent form.
  • Soft contact lens wearer (both eyes).
  • Willing to wear study lenses at least 16 waking hours and attend all study visits.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated.
  • Use of artificial tears and rewetting drops during the study.
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens.
  • History of herpetic keratitis, ocular surgery, or irregular cornea.
  • Pregnant.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Narafilcon A contact lenses

Device

Silicone hydrogel contact lenses for daily disposable wear

Other names: 1-DAY ACUVUE® TruEye® (TruEye)

Stenfilcon A contact lenses

Device

Silicone hydrogel contact lenses for daily disposable wear

Other names: MyDay™

Somofilcon A contact lenses

Device

Silicone hydrogel contact lenses for daily disposable wear

Other names: clariti® 1day

Primary outcomes

  1. Average Coefficient of Friction of Worn Lenses at 16 Hours

    Time frame: Day 1, Hour 16, each product

    Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

Secondary outcomes

  1. Average Coefficient of Friction of Unworn Lenses

    Time frame: Day 1 (each product)

    Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Sep 2, 2016

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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