Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Myopia Clinical Trial

Official title:

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207749
• Other study ID #: CLL949-C018
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: December 17, 2020

Study information

• Verified date: January 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

Description:

Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Understand and sign an IRB/IEC approved Informed Consent form.

• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.

• Successful wear of frequent replacement, spherical, daily wear 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 = 0.75 diopter (D) in each eye.

• Best spectacle corrected visual acuity 20/20 or better in each eye.

• Other protocol-defined 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.

• Monovision contact lens wear.

• Any habitual wear of Biofinity lenses.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Refractive Errors

Intervention

Device:
• LID015385 contact lenses
Investigational soft contact lenses
• Comfilcon A contact lenses
Commercially available soft contact lenses
• CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	Alcon Investigator 8101	Brentwood	California
United States	Alcon Investigator 8063	Brighton	Massachusetts
United States	Alcon Investigator 4817	Cleveland	Ohio
United States	Alcon Investigator 8103	Glendale	Arizona
United States	Alcon Investigator 8102	Irvine	California
United States	Alcon Investigator 8135	Los Angeles	California
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 8100	New York	New York
United States	Alcon Investigator 8115	Norcross	Georgia
United States	Alcon Investigator 8108	Novato	California
United States	Alcon Investigator 8062	Oakland	California
United States	Alcon Investigator 6355	Orlando	Florida
United States	Alcon Investigator 6567	Pittsburg	Kansas
United States	Alcon Investigator 8114	Plano	Texas
United States	Alcon Investigator 6313	Powell	Ohio
United States	Alcon Investigator 8109	San Francisco	California
United States	Alcon Investigator 6401	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 Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)	Visual acuity (VA) was assessed for each eye individually with study lenses in place 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 lower logMAR values indicating better visual acuity.	Week 1 Follow-Up
Secondary	Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)	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, with 20/20 Snellen visual acuity considered normal distance eyesight.	Week 1 Follow-Up, at least 4 hours after lens insertion