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OpenTrials
Completed

NCT Number: NCT03888482

Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Jacksonville, Florida, United States

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About this study

Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
  • Willing and able to attend all scheduled study visits as required per protocol.
  • Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

  • Any ocular condition that contraindicates contact lens wear.
  • Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

Treatment and study plan

Verofilcon A contact lenses

Device

Investigational daily disposable soft contact lenses

Other names: DDT2

Somofilcon A contact lenses

Device

Commercially available daily disposable soft contact lenses

Other names: clariti® 1 day, Clariti

Primary outcomes

  1. Least Squares Mean Distance Visual Acuity With Study Lenses

    Time frame: Day 8, each product

    Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
Jul 13, 2020

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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