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Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

NCT ID: NCT05959200

Last Updated: 2024-11-29

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

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2023-10-23

Brief Summary

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The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Detailed Description

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Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Conditions

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Ametropia Myopia Hyperopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LID226397, then AOfAHP

Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Group Type OTHER

Serafilcon A toric contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Senofilcon A toric contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

AOfAHP, then LID226397

Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Group Type OTHER

Serafilcon A toric contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Senofilcon A toric contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Interventions

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Serafilcon A toric contact lenses

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Intervention Type DEVICE

Senofilcon A toric contact lenses

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID226397 ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS AOfAHP CLEAR CARE® Cleaning and Disinfecting Solution

Eligibility Criteria

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Inclusion Criteria

* Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable 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 be fit with and wear contact lenses within the available range of sphere \& cylinder power and axes.
* Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.

Exclusion Criteria

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).
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, CRD Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Dr. Elsa Pao, OD

Oakland, California, United States

Site Status

Pacific Rims Optometry

San Francisco, California, United States

Site Status

Drs. Giedd, P.A.

Maitland, Florida, United States

Site Status

Vision Health Institute

Orlando, Florida, United States

Site Status

Franklin Park Eye Center, PC

Franklin Park, Illinois, United States

Site Status

ProCare Vision Centers, Inc.

Granville, Ohio, United States

Site Status

Optometry Group, PLLC

Memphis, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLN109-C001

Identifier Type: -

Identifier Source: org_study_id