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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome: 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.


Original Primary Outcome: High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 [ Time Frame: Day 10 ]

TCVA test will be 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 are presented and the percentage of correctly identified rings constitutes the score.


Current Secondary Outcome: 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.


Original Secondary Outcome: Lens Oscillation at Blink at Day 10 [ Time Frame: Day 10 ]

Lens oscillation (rotational stability of the lens on the eye) at blink will be video-recorded. Digital images will be used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation (in °).


Information By: Alcon Research

Dates:
Date Received: February 24, 2014
Date Started: April 2014
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015