Performance Assessment of a Modified Da… | Clinical Trial

Key information

Conditions

Refractive Errors Eye Diseases Hyperopia Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Maitland, Florida, United States

About this study

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

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 approved Informed Consent form;
Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
Monocular (only one eye with functional vision);
Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Modified delefilcon A contact lenses

Device

Spherical soft daily disposable contact lens

Other names: MDACL

Delefilcon A contact lenses

Device

Spherical soft daily disposable contact lens

Other names: DACL

Primary outcomes

High Contrast Distance Visual Acuity (logMAR)

Time frame: Day 1 Dispense, Day 7 Follow-Up

Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Dec 4, 2018
Registry last updated: Jan 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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Completed