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OpenTrials
Completed

NCT Number: NCT04464044

Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Completed

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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

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 informed consent form;
  • Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
  • Willing to NOT use rewetting/lubricating drops at any time during the study;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
  • History of eye surgery within the previous 12 months, as specified in the protocol;
  • Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

verofilcon A toric contact lenses

Device

Daily disposable toric soft contact lenses

Other names: DDT2 Toric

Primary outcomes

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

    Time frame: Day 1, 10 minutes after lens insertion

    Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2020
Registry last updated
Aug 19, 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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