Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses

• Registration Number: NCT02388763
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

Detailed Description

After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Study Timeline

• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-08-25
• Results First Submitted QC: 2016-08-25
• Status Verified: 2016-10
• Results First Posted: 2016-10-19
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Must sign informed consent form.
• Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
• Willing to wear lenses every day or at least 5 days per week 6 hours per day.
• Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Monocular (only 1 eye with functional vision) or fit with only 1 lens.
• Pregnant or lactating.
• Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
• Any abnormal ocular condition as specified in the protocol.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MyDay, then 1DAVTE	Stenfilcon A contact lenses	Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
1DAVTE, then MyDay	Stenfilcon A contact lenses	Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
1DAVTE, then MyDay	Narafilcon A contact lenses	Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
MyDay, then 1DAVTE	Narafilcon A contact lenses	Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.

Primary Outcome Measures

Name	Time	Method
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10	Day 10, each product	High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. 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
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10	Day 10, each product	High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.