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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05483127
Other study ID # CLA306-P002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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