Two Daily Disposable Contact Lenses in Symptomatic Patients

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lenses; Device: Senofilcon A contact lenses

• Registration Number: NCT03628599
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-09
• Study Start: 2018-08-13
• Study First Posted: 2018-08-14
• Primary Completion: 2018-09-25
• Study Completion: 2018-09-25
• Status Verified: 2019-06
• Results First Submitted: 2019-06-13
• Results First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Able to understand and must sign an IRB-approved informed consent form;
• Soft contact lens wearers in both eyes during the past 3 months;
• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
• Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
• Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria

• Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
• Intolerance, hypersensitivity, or allergy to any component of the study products;
• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Monocular (only one eye with functional vision).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOTAL1	Delefilcon A contact lenses	Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
1-DAY	Senofilcon A contact lenses	Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality

Primary Outcome Measures

Name	Time	Method
Monocular Corrected Distance Visual Acuity (VA)	Week 4	Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Warwick, Rhode Island, United States