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

NCT02696317 | Completed Results

• 1 other identifier: CLE198-P001
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)

  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)

  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)

  Day 10 ± 3 days, each product

Study Arms (2)

AO1D, then AO

OTHER

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™; Device: Senofilcon A contact lenses

AO, then AO1D

OTHER

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™; Device: Senofilcon A contact lenses

Interventions

Senofilcon A contact lenses with HydraLuxe™ DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Also known as: ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D)

AO, then AO1D; AO1D, then AO

Senofilcon A contact lenses DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Also known as: ACUVUE® OASYS® (AO)

AO, then AO1D; AO1D, then AO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Sr. Brand Lead, Global Medical Affairs, Vision Care
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Senior Clinical Manager, GCRA Operations

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 2, 2016
• Study Start: March 18, 2016
• Primary Completion: June 6, 2016
• Study Completion: June 6, 2016
• Last Updated: July 2, 2018
• Results First Posted: June 26, 2017

Record last verified: 2017-09