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NCT04908488 Clinical Trial

Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Astigmatism Clinical Trial

Official title:
Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04908488
Other study ID # CLA306-P001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date September 22, 2021

Study information
Verified date September 2022
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Description:

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date September 22, 2021
Est. primary completion date September 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers. - Any spherical monovision and multifocal lens wearers. - Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment. - Other protocol-defined exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Verofilcon A toric contact lenses
Soft contact lenses for optical correction of astigmatism
• Etafilcon A toric contact lenses
Soft contact lenses for optical correction of astigmatism

Locations
Country Name City State
United States Alcon Investigator 6614 Franklin Park Illinois
United States Alcon Investigator 8135 Los Angeles California
United States Alcon Investigator 2786 Memphis Tennessee
United States Alcon Investigator 6353 Memphis Tennessee
United States Alcon Investigator 8062 Oakland California
United States Alcon Investigator 6355 Orlando Florida
United States Alcon Investigator 6645 Shawnee Mission Kansas
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 days), each study lens type
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