Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483127
• Other study ID #: CLA306-P002
• Status: Completed
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: October 31, 2022

Study information

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

Clinical Trial Summary

The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

Description:

Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.

• Able to wear contact lenses within a range of sphere & cylinder power and axes.

• Willing to NOT use rewetting/lubricating drops at any time during the study.

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current or previous P1fA and MDT habitual lens wearers.

• Monovision and multifocal lens wearers.

• Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Ametropia
• Astigmatism
• Myopia
• Refractive Errors

Intervention

Device:
• Verofilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism
• Stenfilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism

Locations

Country	Name	City	State
United States	Franklin Park Eye Center	Franklin Park	Illinois
United States	ProCare Vision Center	Granville	Ohio
United States	Sabal Eye Care	Longwood	Florida
United States	Kurata Eyecare Center	Los Angeles	California
United States	Drs. Giedd, P.A.	Maitland	Florida
United States	Wesley Optometric Consulting	Medina	Minnesota
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Vision Health Institute	Orlando	Florida
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas
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 Means Distance Visual Acuity With Study Lenses at Week 1	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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 8 of each study lens type worn during the corresponding crossover period