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OpenTrials
Completed

NCT Number: NCT02388763

Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

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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

After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must sign informed consent form.
  • Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
  • Willing to wear lenses every day or at least 5 days per week 6 hours per day.
  • Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Monocular (only 1 eye with functional vision) or fit with only 1 lens.
  • Pregnant or lactating.
  • Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
  • Any abnormal ocular condition as specified in the protocol.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Stenfilcon A contact lenses

Device

Contact lenses worn during Period 1 or 2, as randomized

Other names: MyDay™

Narafilcon A contact lenses

Device

Contact lenses worn during Period 1 or 2, as randomized

Other names: 1-DAY ACUVUE® TruEye®

Primary outcomes

  1. High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10

    Time frame: Day 10, each product

    High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

Secondary outcomes

  1. High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10

    Time frame: Day 10, each product

    High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
Dec 5, 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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