Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Alcon Research153 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

153

Conditions

Astigmatism Ametropia Myopia

Interventions

Verofilcon A toric soft contact lensesDEVICE

Soft contact lenses for optical correction of ametropia and astigmatism

Stenfilcon A toric soft contact lensesDEVICE

Soft contact lenses for optical correction of ametropia and astigmatism

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Kurata Eyecare Center

Los Angeles, California, United States

Sabal Eye Care

Longwood, Florida, United States

Drs. Giedd, P.A.

Maitland, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 8 of each study lens type worn during the corresponding crossover period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.