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

N/ACompletedNCT02071771

Alcon Research80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Astigmatism

Interventions

Nelfilcon A toric contact lensesDEVICE

Etafilcon A toric contact lensesDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Day 10, each product

Secondary Outcomes

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.

Time frame: Day 10, each product

Data from ClinicalTrials.gov

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