DD T2 Daily Disposable Registration Trial

NCT03305770 | Completed Results FDA Device

• 1 other identifier: CLE383-C005
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

Conditions

Myopia; Refractive Errors

Keywords

soft contact lenses; vision; eyesight

Outcome Measures

Primary Outcomes (1)

• Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)

  VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.

  Dispense, Week 1, Week 2, Month 1, Month 2, Month 3

Study Arms (2)

DD T2

EXPERIMENTAL

Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.

Device: verofilcon A contact lenses

DT 1

ACTIVE COMPARATOR

Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.

Device: delefilcon A contact lenses

Interventions

verofilcon A contact lenses DEVICE

Daily disposable soft contact lenses

Also known as: DD T2

DD T2

delefilcon A contact lenses DEVICE

Daily disposable soft contact lenses

Also known as: DAILIES TOTAL1®, DT1

DT 1

Eligibility Criteria

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

You may qualify if:

• Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Best corrected VA 20/25 or better in each eye.

You may not qualify if:

• Any current or prior wear experience with DT1 lenses.
• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (6)

Alcon Investigative Site

San Diego, California, 92123, United States

Location

Alcon Investigative Site

Longwood, Florida, 32779, United States

Location

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Bloomington, Illinois, 61701, United States

Location

Alcon Investigative Site

Brentwood, Tennessee, 37027, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr Director Project Leadership
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon, a Novartis Division

  Alcon, a Novartis Division

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 10, 2017
• Study Start: October 12, 2017
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: February 22, 2019
• Results First Posted: February 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)