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OpenTrials
Completed

NCT Number: NCT02072980

DAILIES TOTAL1® Lubricity Post Wear

The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

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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

In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated 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

  • Willing and able to sign Informed Consent document.
  • Adapted, current soft contact lens wearer.
  • Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
  • Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
  • Vision correctable to 20/25 or better in each eye at distance with study lenses.
  • Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
  • Able to be successfully fitted with study lenses.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
  • Use of artificial tears and rewetting drops during the study.
  • Monocular (only one eye with functional vision) or fit with only one lens.
  • Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
  • History of herpetic keratitis, ocular surgery, or irregular cornea.
  • Pregnant.
  • Participation in any clinical study within 30 days of Visit 1.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Silicone hydrogel contact lenses

Other names: DAILIES TOTAL1®

Primary outcomes

  1. Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn

    Time frame: Day 1 (for each period), 16 hours

    Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF 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 at 15 Minutes

    Time frame: Day 1 (for each period), 15 minutes

    Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2014
Registry last updated
May 14, 2015

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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