Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Must sign an Informed Consent document;
Wear toric soft contact lenses within the protocol-specified range;
Cylinder equal or higher than -0.75 diopters (D) in both eyes;
Have an acceptable fit with both study contact lenses;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
Best corrected visual acuity (BCVA) of 20/30 Snellen;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Require presbyopic correction;
Any ocular condition observed during examination at the enrollment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;
Pregnant or lactating;
Participation in any clinical trial within 30 days of the enrollment visit;
Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Nelfilcon A toric contact lenses

Device

Other names: DACP Toric, DAILIES® AQUACOMFORT PLUS® TORIC

Etafilcon A toric contact lenses

Device

Other names: 1-DAY ACUVUE® MOIST® for Astigmatism

Primary outcomes

High Contrast Time Controlled Visual Acuity (TCVA) at Day 10

Time frame: Day 10, each product

TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

Secondary outcomes

Lens Oscillation at Blink at Day 10

Time frame: Day 10, each product

Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 26, 2014
Registry last updated: Nov 10, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed