Clinical Comparison of Toric Contact Lenses Fit Characteristics

May 18, 2023 updated by: Alcon Research
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.

Study Type

Interventional

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, 90013
        • Kurata Eyecare Center
    • Florida
      • Longwood, Florida, United States, 32779
        • Omega Vision Center P.A.
      • Maitland, Florida, United States, 32751
        • Kindred Optics at Maitland Vision
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care LLC
    • Ohio
      • Granville, Ohio, United States, 43023
        • Procare Vision Centers, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC
    • Texas
      • Wichita Falls, Texas, United States, 76308
        • Clarke EyeCare Center

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 wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
  • Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
  • Willing to stop wearing habitual contact lenses during in-office visits.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current spherical, monovision or multifocal lens wearer.
  • Protocol-specified biomicroscopy findings at screening.
  • Current or history of herpetic keratitis in either eye.
  • Participation 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: DT1fA/T30fA/AOHGfA/P1fA
DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • DT1fA
  • DAILIES TOTAL1® for Astigmatism
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • T30fA
  • TOTAL30™ for Astigmatism
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • AOHGfA
  • AIR OPTIX® plus HydraGlyde® for Astigmatism
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • P1fA
  • PRECISION1® for Astigmatism
Other: T30fA/AOHGfA/P1fA/DT1fA
T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • DT1fA
  • DAILIES TOTAL1® for Astigmatism
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • T30fA
  • TOTAL30™ for Astigmatism
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • AOHGfA
  • AIR OPTIX® plus HydraGlyde® for Astigmatism
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • P1fA
  • PRECISION1® for Astigmatism
Other: AOHGfA/P1fA/DT1fA/T30fA
AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • DT1fA
  • DAILIES TOTAL1® for Astigmatism
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • T30fA
  • TOTAL30™ for Astigmatism
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • AOHGfA
  • AIR OPTIX® plus HydraGlyde® for Astigmatism
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • P1fA
  • PRECISION1® for Astigmatism
Other: P1fA/DT1fA/T30fA/AOHGfA
P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • DT1fA
  • DAILIES TOTAL1® for Astigmatism
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • T30fA
  • TOTAL30™ for Astigmatism
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • AOHGfA
  • AIR OPTIX® plus HydraGlyde® for Astigmatism
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
  • P1fA
  • PRECISION1® for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance VA with study lenses
Time Frame: 30 mins (± 15 mins), each product
Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
30 mins (± 15 mins), each product

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Chair: 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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLF993-P001

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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