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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055519
• Other study ID #: CLY935-C007
• Status: Completed
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: December 3, 2019

Study information

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

Clinical Trial Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Description:

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign Informed Consent document.

• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.

• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any eye condition or disease or use of medication that contraindicates contact lens wear.

• Eye surgery, irregular cornea, eye injury as specified in the protocol.

• Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.

• Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.

• Habitually wears Biofinity contact lenses.

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
• Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
• Multi-purpose disinfection solution
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

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

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance VA (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). 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 30 after a minimum of 6 hours of wear, each product