Two Daily Disposable Contact Lenses in Symptomatic Patients

NCT03628599 | Completed Results FDA Device

• 1 other identifier: CLS312-P001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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.

Conditions

Myopia

Keywords

Symptomatic

Outcome Measures

Primary Outcomes (1)

• Monocular Corrected Distance Visual Acuity (VA)

  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.

  Week 4

Study Arms (2)

TOTAL1

EXPERIMENTAL

Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality

Device: Delefilcon A contact lenses

1-DAY

ACTIVE COMPARATOR

Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality

Device: Senofilcon A contact lenses

Interventions

Delefilcon A contact lenses DEVICE

Water Gradient silicon hydrogel daily disposable contact lenses

Also known as: DAILIES TOTAL1® (DT1)

TOTAL1

Senofilcon A contact lenses DEVICE

Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology

Also known as: ACUVUE OASYS® 1-DAY

1-DAY

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Alcon Investigative Site

Bloomington, Illinois, 61701, United States

Location

Alcon Investigative Site

Pittsburg, Kansas, 66762, United States

Location

Alcon Investigative Site

Powell, Ohio, 43065, United States

Location

Alcon Investigative Site

Warwick, Rhode Island, 02888, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: CDMA Project Lead
• Organization: Alcon Research

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon Research

  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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: August 13, 2018
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)