Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050578
• Other study ID #: CLY935-C022
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: March 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Description:

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.

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

• Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Monovision or multifocal lens wearer.

• Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).

• Routinely sleeps in habitual contact lenses.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lenses
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
• Senofilcon A contact lenses
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
• CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	North Spartanburg Eye Center	Boiling Springs	South Carolina
United States	Sabal Eye Care	Longwood	Florida
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Dr. Elsa Pao, OD	Oakland	California
United States	Vision Health Institute	Orlando	Florida
United States	Dr Christina R Chang & Associates, OD, PA	Plano	Texas
United States	Dawn M. Rakich, OD	San Antonio	Texas
United States	Pacific Rims Optometry	San Francisco	California
United States	Advancing Vision Research, LLC	Smyrna	Tennessee
United States	West Bay Eye Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30	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.	Day 30, each study lens type