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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03305770
Other study ID # CLE383-C005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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