DD T2 Daily Disposable Registration Trial

Myopia Clinical Trial

Official title:

DD T2 Daily Disposable Registration Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305770
• Other study ID #: CLE383-C005
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: February 21, 2018

Study information

• Verified date: January 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 21, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• 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.

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Device:
• verofilcon A contact lenses
Daily disposable soft contact lenses
• delefilcon A contact lenses
Daily disposable soft contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Brentwood	Tennessee
United States	Alcon Investigative Site	Longwood	Florida
United States	Alcon Investigative Site	Maitland	Florida
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website