Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010512
• Other study ID #: CLU484-P002
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: October 12, 2021

Study information

• Verified date: October 2022
• 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 DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Description:

Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
• At least 3 months of contact lens wearing experience;
• Less than or equal to 0.75 diopter (D) astigmatism in each eye;
• Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
• Monovision and/or multifocal lens wearer;
• Routinely sleeps in habitual contact lenses.
• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Ametropia
• Myopia
• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses
Commercially available silicone hydrogel contact lenses used as indicated
• Kalifilcon A contact lenses
Commercially available silicone hydrogel contact lenses used as indicated

Locations

Country	Name	City	State
United States	Alcon Investigator 3950	Bloomington	Illinois
United States	Alcon Investigator 6583	Eden Prairie	Minnesota
United States	Alcon Investigator 6614	Franklin Park	Illinois
United States	Alcon Investigator 2786	Memphis	Tennessee
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 6355	Orlando	Florida
United States	Alcon Investigator 6418	Tallahassee	Florida
United States	Alcon Investigator 3382	Wyomissing	Pennsylvania

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 VA (logMAR) With Study Lenses	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 8 (-0/+3), each study lens type