Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Refractive Errors Clinical Trial

Official title:

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178720
• Other study ID #: CLY935-C010
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: June 10, 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 clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Description:

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 10, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement 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.

• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• 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.

• Habitually wearing Biofinity contact lenses.

• Monovision contact lens wearers.

• 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
• CLEAR CARE
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Granville	Ohio
United States	Alcon Investigative Site	Longwood	Florida
United States	Alcon Investigative Site	Maitland	Florida
United States	Alcon Investigative Site	Medina	Minnesota
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Memphis	Tennessee
United States	Alcon Investigative Site	Orlando	Florida

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 - Completed Eyes	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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.	Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Primary	Distance VA (logMAR) With Study Lenses - Discontinued Eyes	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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.	Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up