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Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

NCT ID: NCT04178720

Last Updated: 2021-10-19

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

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2020-06-10

Brief Summary

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The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Detailed Description

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Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LID018869

Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.

Group Type EXPERIMENTAL

Lehfilcon A contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses

Biofinity

Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.

Group Type ACTIVE_COMPARATOR

Comfilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses

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 system for cleaning and disinfecting silicone hydrogel contact lenses

Intervention Type DEVICE

Other Intervention Names

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LID018869 CooperVision® BIOFINITY® Biofinity CLEAR CARE® Cleaning & Disinfecting Solution

Eligibility Criteria

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Inclusion Criteria

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.

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.
* Habitually wearing Biofinity contact lenses.
* Monovision contact lens wearers.
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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CDMA Project Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigative Site

Longwood, Florida, United States

Site Status

Alcon Investigative Site

Maitland, Florida, United States

Site Status

Alcon Investigative Site

Orlando, Florida, United States

Site Status

Alcon Investigative Site

Bloomington, Illinois, United States

Site Status

Alcon Investigative Site

Medina, Minnesota, United States

Site Status

Alcon Investigative Site

Granville, Ohio, United States

Site Status

Alcon Investigative Site

Memphis, Tennessee, 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-C010

Identifier Type: -

Identifier Source: org_study_id