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OpenTrials
Completed

NCT Number: NCT03095027

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Longwood, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and sign an IRB-approved Informed Consent Form;
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
  • Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
  • Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • History of refractive surgery or plan to have refractive surgery during the study;
  • Ocular or intraocular surgery within the previous 12 months or planned during the study;
  • Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
  • Any previous or current wear of MYDAY;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;
  • Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

FID122819 contact lenses

Device

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Other names: DDT2, Verofilcon A

Stenfilcon A contact lenses

Device

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Other names: MyDay®

Primary outcomes

  1. Visual Acuity (VA)

    Time frame: Baseline/Dispense (Day 1), Week 1, each product

    VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2017
Registry last updated
Feb 4, 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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