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

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

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).

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Nelfilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DACP T, Then 1DAM A; Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.	Device: Nelfilcon A toric contact lenses; Other Names: DACP Toric; DAILIES® AQUACOMFORT PLUS® TORIC; Device: Etafilcon A toric contact lenses; Other Names: 1-DAY ACUVUE® MOIST® for Astigmatism
Other: 1DAM A, Then DACP T; Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.	Device: Nelfilcon A toric contact lenses; Other Names: DACP Toric; DAILIES® AQUACOMFORT PLUS® TORIC; Device: Etafilcon A toric contact lenses; Other Names: 1-DAY ACUVUE® MOIST® for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10	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.	Day 10, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Oscillation at Blink at Day 10	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.	Day 10, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, EMEA, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: DACP Toric; DAILIES® AquaComfort Plus®; Astigmatism; Toric
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: M-14-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No