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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type OTHER

Nelfilcon A toric contact lenses

Intervention Type DEVICE

Etafilcon A toric contact lenses

Intervention Type DEVICE

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.

Group Type OTHER

Nelfilcon A toric contact lenses

Intervention Type DEVICE

Etafilcon A toric contact lenses

Intervention Type DEVICE

Interventions

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Nelfilcon A toric contact lenses

Intervention Type DEVICE

Etafilcon A toric contact lenses

Intervention Type DEVICE

Other Intervention Names

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DACP Toric DAILIES® AQUACOMFORT PLUS® TORIC 1-DAY ACUVUE® MOIST® for Astigmatism

Eligibility Criteria

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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;

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No