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

Not Applicable

Completed

Interventions: Device: Nelfilcon A toric contact lenses
Device: Etafilcon A toric contact lenses

Brief Summary: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
DACP T, Then 1DAM A	Nelfilcon A toric contact lenses	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.
1DAM A, Then DACP T	Nelfilcon A toric contact lenses	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.
DACP T, Then 1DAM A	Etafilcon A toric contact lenses	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.
1DAM A, Then DACP T	Etafilcon A toric contact lenses	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.

Primary Outcome Measures

Name	Time	Method
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10	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 Outcome Measures

Name	Time	Method
Lens Oscillation at Blink at Day 10	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.