Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®

Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses

The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Senofilcon A contact lenses with HydraLuxe™; Device: Senofilcon A contact lenses

Detailed Description

After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.

• Study Type: Interventional
• Enrollment (Actual): 84
• 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 an informed consent form;
• Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
• Prescription within power range of both study contact lenses, as stated in the protocol;
• Cylinder equal or lower than -0.75 diopter (D) in both eyes;
• Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
• Willing to discontinue artificial tears and rewetting drops on the days of study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Current AO1D or AO lens wearer;
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AO1D, then AO; Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.	Device: Senofilcon A contact lenses with HydraLuxe™; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D); Device: Senofilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® (AO)
Other: AO, then AO1D; Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.	Device: Senofilcon A contact lenses with HydraLuxe™; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D); Device: Senofilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® (AO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)	Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.	Day 10 ± 3 days, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)	Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.	Day 10 ± 3 days, each product
Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)	MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.	Day 10 ± 3 days, each product
Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)	MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.	Day 10 ± 3 days, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Senior Clinical Manager, GCRA Operations, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2016
• Primary Completion (Actual): June 6, 2016
• Study Completion (Actual): June 6, 2016

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE198-P001