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

NCT ID: NCT02696317

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-18
• Study Completion Date: 2016-06-06

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.

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.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Senofilcon A contact lenses with HydraLuxe™

Intervention Type: DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Senofilcon A contact lenses

Intervention Type: DEVICE

Contact lenses worn during Period 1 or 2, as randomized

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.

Group Type: OTHER

Senofilcon A contact lenses with HydraLuxe™

Intervention Type: DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Senofilcon A contact lenses

Intervention Type: DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Interventions

Senofilcon A contact lenses with HydraLuxe™

Contact lenses worn during Period 1 or 2, as randomized

Intervention Type: DEVICE

Senofilcon A contact lenses

Contact lenses worn during Period 1 or 2, as randomized

Intervention Type: DEVICE

Other Intervention Names

ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D); ACUVUE® OASYS® (AO)

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Clinical Manager, GCRA Operations

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

CLE198-P001

Identifier Type: -

Identifier Source: org_study_id