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OpenTrials
Completed

NCT Number: NCT02517567

DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign an informed consent document;
  • Adapted, current soft contact lens wearer;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
  • Can be successfully fitted with study lenses;
  • Willing to wear lenses for a minimum of 8 hours prior to each study visit;
  • Willing to discontinue artificial tears and rewetting drops usage on the days of 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 as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only one lens;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Known pregnancy and lactation;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Other names: DAILIES TOTAL1®

Narafilcon A contact lenses

Device

Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Other names: 1-DAY ACUVUE® TruEye®

Somofilcon A contact lenses

Device

Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Other names: clariti® 1 day

Primary outcomes

  1. Tear Film Evaporation Rate

    Time frame: Day 1, Hour 8, each product

    Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2015
Registry last updated
Jul 2, 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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