ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Senofilcon A contact lenses; Device: Delefilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02750813

CLV771-P001

Details and patient eligibility

About

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign informed consent form;
• Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
• Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
• Cylinder equal or lower than -0.75D in both eyes;
• Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
• Can be successfully fitted with both study lenses at Visit 1;
• Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all 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;
• Fitted with monovision;
• Prior refractive surgery;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
• Participation in any clinical study within 30 days of Visit 1;
• Current DT1 or AO1D lens wearer;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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252 participants in 2 patient groups

DT1, then AO1D

Other group

Description:

Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.

Treatment:

Device: Delefilcon A contact lenses

Device: Senofilcon A contact lenses

AO1D, then DT1

Other group

Description:

Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.

Treatment:

Device: Delefilcon A contact lenses

Device: Senofilcon A contact lenses