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

Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MyDay, then 1DAVTE; 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.	Device: Stenfilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: MyDay™; Device: Narafilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: 1-DAY ACUVUE® TruEye®
Other: 1DAVTE, then MyDay; Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.	Device: Stenfilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: MyDay™; Device: Narafilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: 1-DAY ACUVUE® TruEye®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10	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.	Day 10, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10	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.	Day 10, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Manager, EMEA, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY838-P001