Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Myopia Clinical Trial

Official title:

Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476784
• Other study ID #: CLY935-C013
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: November 18, 2020

Study information

• Verified date: September 2021
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Description:

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;

• Willing and able to attend all scheduled study visits as required by the protocol;

• Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current or prior Biofinity contact lens wearer in the past 3 months;

• Monovision contact lens wearer;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
• Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
• CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Maitland	Florida
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Pittsburg	Kansas
United States	Alcon Investigative Site	Shawnee Mission	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Distance Visual Acuity (logMAR) With Study Lenses	Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.	Day 1, Day 30 after 6-8 hours of wear, each product