Performance Assessment of a Modified Daily Disposable Contact Lens

NCT ID: NCT03762668

Last Updated: 2020-01-13

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-01-07

Brief Summary

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The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Detailed Description

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The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Conditions

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Refractive Errors Myopia Hyperopia

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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MDACL, then DACL

Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.

Group Type OTHER

Modified delefilcon A contact lenses

Intervention Type DEVICE

Spherical soft daily disposable contact lens

Delefilcon A contact lenses

Intervention Type DEVICE

Spherical soft daily disposable contact lens

DACL, then MDACL

DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.

Group Type OTHER

Modified delefilcon A contact lenses

Intervention Type DEVICE

Spherical soft daily disposable contact lens

Delefilcon A contact lenses

Intervention Type DEVICE

Spherical soft daily disposable contact lens

Interventions

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Modified delefilcon A contact lenses

Spherical soft daily disposable contact lens

Intervention Type DEVICE

Delefilcon A contact lenses

Spherical soft daily disposable contact lens

Intervention Type DEVICE

Other Intervention Names

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MDACL DACL

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an approved Informed Consent form;
* Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;

Exclusion Criteria

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
* Monocular (only one eye with functional vision);
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. CDMA Project Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Alcon Investigative Site

Maitland, Florida, United States

Site Status

Alcon Investigative Site

Orlando, Florida, United States

Site Status

Alcon Investigative Site

West Palm Beach, Florida, United States

Site Status

Alcon Investigative Site

Ann Arbor, Michigan, 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: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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CLP691-C002

Identifier Type: -

Identifier Source: org_study_id

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