ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

NCT ID: NCT02750813

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-27
• Study Completion Date: 2016-08-17

Brief Summary

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.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DT1, then AO1D

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.

Group Type: OTHER

Delefilcon A contact lenses

Intervention Type: DEVICE

Senofilcon A contact lenses

Intervention Type: DEVICE

AO1D, then DT1

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.

Group Type: OTHER

Delefilcon A contact lenses

Intervention Type: DEVICE

Senofilcon A contact lenses

Intervention Type: DEVICE

Interventions

Delefilcon A contact lenses

Intervention Type: DEVICE

Senofilcon A contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL1® (DT1); ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)

Eligibility Criteria

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;

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;

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

Sponsors

Alcon, a Novartis Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Manager, Global Medical Affairs, GCRA

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

CLV771-P001

Identifier Type: -

Identifier Source: org_study_id