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Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

NCT ID: NCT04476784

Last Updated: 2021-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2020-11-18

Brief Summary

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The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Detailed Description

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Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Conditions

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Myopia

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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LID018869, then Biofinity

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Biofinity, then LID018869

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Interventions

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Lehfilcon A contact lenses

Investigational silicone hydrogel contact lenses

Intervention Type DEVICE

Comfilcon A contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide-based cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID018869 CooperVision® BIOFINITY® Biofinity

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an approved Informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;

Exclusion Criteria

* Current or prior Biofinity contact lens wearer in the past 3 months;
* Monovision contact lens wearer;
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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Sr. Clinical Trial Lead, CDMA Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigative Site

Maitland, Florida, United States

Site Status

Alcon Investigative Site

Bloomington, Illinois, United States

Site Status

Alcon Investigative Site

Pittsburg, Kansas, United States

Site Status

Alcon Investigative Site

Shawnee Mission, Kansas, United States

Site Status

Alcon Investigative Site

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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CLY935-C013

Identifier Type: -

Identifier Source: org_study_id