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OpenTrials
Completed

NCT Number: NCT04254003

Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

The purpose of this study is to evaluate the rotational behavior of DT1 Toric 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 CT-11, Maitland, Florida, United States

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About this study

This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
  • Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
  • Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
  • Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any anterior segment infection, inflammation, or 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 or irregular cornea in either eye.
  • Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

DT1 Toric contact lenses

Device

Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)

Other names: Test, DAILIES TOTAL1 for Astigmatism (DT1 Toric)

AO1DfA contact lenses

Device

Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)

Other names: Control, Acuvue Oasys 1-Day for Astigmatism (AO1DfA)

Primary outcomes

  1. Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion

    Time frame: Day 1, 10 minutes after lens insertion, each product

    A slit lamp will be used to observe axis orientation.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Mar 18, 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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