Skip to main content
OpenTrials
Completed

NCT Number: NCT01371552

Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Completed

Looking for future studies?

Notify Me

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 Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

About this study

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 17 years of age; full legal capacity to volunteer.
  • Ocular examination within the last two years
  • Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
  • Currently wearing soft contact lenses.
  • Clear corneas; no active ocular disease.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
  • Monovision.
  • Any ocular disease.
  • Never worn contact lenses before.
  • Corneal refractive surgery.
  • Uses topical ocular medicine.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

delefilcon A contact lens

Device

Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.

filcon II 3 contact lenses

Device

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Other names: Clariti 1-DAY

Narafilcon A contact lenses

Device

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Other names: 1-DAY ACUVUE TruEye

Primary outcomes

  1. Mean Value of Comfort During the Day

    Time frame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours

    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.

  2. Mean Overall Comfort Given at End of Wear

    Time frame: Part 1: Day 3

    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.

  3. Mean Overall Quality of Vision at End of Wear

    Time frame: Part 1: Day 3

    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.

  4. Mean Overall Ease of Handling at End of Wear

    Time frame: Part 1: Day 3

    The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day.

  5. Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear

    Time frame: Part 1: Day 2

    The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day.

  6. Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear

    Time frame: Part 1: Day 3

    The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day.

  7. Lens Wettability

    Time frame: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours

    Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.

  8. Percentage of Participants Responding "Yes"

    Time frame: Part 2: Day 7

    The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Official study title

Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)

Acronym: TUNGSTEN

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2011
Registry last updated
Oct 31, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.