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OpenTrials
Completed

NCT Number: NCT03305770

DD T2 Daily Disposable Registration Trial

The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, San Diego, California, United States

Loading trial locations.

About this study

Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
  • Best corrected VA 20/25 or better in each eye.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any current or prior wear experience with DT1 lenses.
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Verofilcon A contact lenses

Device

Daily disposable soft contact lenses

Other names: DD T2

Delefilcon A contact lenses

Device

Daily disposable soft contact lenses

Other names: DAILIES TOTAL1®, DT1

Primary outcomes

  1. Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)

    Time frame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3

    VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2017
Registry last updated
Feb 22, 2019

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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