Clinical Comparison of Toric Contact Lenses Fit Characteristics

NCT ID: NCT05805345

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2023-05-31

Brief Summary

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The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.

Detailed Description

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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.

Conditions

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Astigmatism Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

Delefilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lehfilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lotrafilcon B toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Verofilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

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.

Group Type OTHER

Delefilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lehfilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lotrafilcon B toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Verofilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

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.

Group Type OTHER

Delefilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lehfilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lotrafilcon B toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Verofilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

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.

Group Type OTHER

Delefilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lehfilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Lotrafilcon B toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Verofilcon A toric soft contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Interventions

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Delefilcon A toric soft contact lens

Commercially available silicone hydrogel contact lens

Intervention Type DEVICE

Lehfilcon A toric soft contact lens

Commercially available silicone hydrogel contact lens

Intervention Type DEVICE

Lotrafilcon B toric soft contact lens

Commercially available silicone hydrogel contact lens

Intervention Type DEVICE

Verofilcon A toric soft contact lens

Commercially available silicone hydrogel contact lens

Intervention Type DEVICE

Other Intervention Names

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DT1fA DAILIES TOTAL1® for Astigmatism T30fA TOTAL30™ for Astigmatism AOHGfA AIR OPTIX® plus HydraGlyde® for Astigmatism P1fA PRECISION1® for Astigmatism

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Vision Care

Role: STUDY_CHAIR

Alcon Research, LLC

Locations

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Kurata Eyecare Center

Los Angeles, California, United States

Site Status

Omega Vision Center P.A.

Longwood, Florida, United States

Site Status

Kindred Optics at Maitland Vision

Maitland, Florida, United States

Site Status

Kannarr Eye Care LLC

Pittsburg, Kansas, United States

Site Status

ProCare Vision Centers, Inc.

Granville, Ohio, United States

Site Status

Optometry Group, PLLC

Memphis, Tennessee, United States

Site Status

Clarke EyeCare Center

Wichita Falls, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CLF993-P001

Identifier Type: -

Identifier Source: org_study_id

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