Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

October 9, 2023 updated by: Alcon Research
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90012
        • Kurata Eyecare Center
    • Florida
      • Longwood, Florida, United States, 32779
        • Sabal Eye Care
      • Maitland, Florida, United States, 32751
        • Drs. Giedd, P.A.
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
    • Illinois
      • Franklin Park, Illinois, United States, 60131
        • Franklin Park Eye Center
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care
      • Shawnee Mission, Kansas, United States, 66204
        • Heart of America Eye Care, P.A.
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Wesley Optometric Consulting
    • Ohio
      • Granville, Ohio, United States, 43023
        • ProCare Vision Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • West Bay Eye Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: P1fA, then MDT
Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.
Device: Verofilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism
Other Names:
  • PRECISION1™ for Astigmatism
  • P1fA
Device: Stenfilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism
Other Names:
  • MyDay® toric soft contact lenses
  • MDT
Other: MDT, then P1fA
Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.
Device: Verofilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism
Other Names:
  • PRECISION1™ for Astigmatism
  • P1fA
Device: Stenfilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism
Other Names:
  • MyDay® toric soft contact lenses
  • MDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
Time Frame: Day 8 of each study lens type worn during the corresponding crossover period
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Sr. Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLA306-P002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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