Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2023-07-17

Brief Summary

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The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

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Detailed Description

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Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Conditions

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Refractive Errors Presbyopia Astigmatism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Subjects will wear the products (test and comparator) in a predetermined order.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LID223188, then Ultra MFT

Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Group Type OTHER

Lehfilcon A multifocal toric contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

Samfilcon A multifocal toric contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Ultra MFT, then LID223188

Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Group Type OTHER

Lehfilcon A multifocal toric contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

Samfilcon A multifocal toric contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Interventions

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Lehfilcon A multifocal toric contact lenses

Investigational silicone hydrogel contact lenses

Intervention Type DEVICE

Samfilcon A multifocal toric contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID223188 Ultra MFT Bausch + Lomb Ultra® Multifocal for Astigmatism CLEAR CARE® Cleaning and Disinfecting Solution

Eligibility Criteria

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Inclusion Criteria

* Requires ADD (additional power for near vision);
* Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
* Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
* Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.

Exclusion Criteria

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Monovision contact lens wear.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No