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OpenTrials
Completed

NCT Number: NCT03518008

Clinical Comparison of Two Daily Disposable Soft Contact Lenses

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

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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

Maitland, Florida, 32751, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Understand and sign an Informed Consent Form;
  • Successful wear of daily disposable 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;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Anterior segment infection, inflammation, or abnormality or disease that contraindicates 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;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Eye condition or injury, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
  • 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;
  • Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
  • Currently wearing clariti® 1 day contact lenses;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Verofilcon A contact lenses

Device

Investigational daily disposable soft contact lenses

Other names: DD T2

Somofilcon A contact lenses

Device

Commercially available daily disposable soft contact lenses

Other names: clariti® 1 day, Clariti 1 Day

Primary outcomes

  1. Overall Quality of Vision

    Time frame: Day 8, each product

    Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 8, 2018
Registry last updated
Apr 3, 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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