Evaluation of Delefilcon A Contact Lenses

NCT ID: NCT06884202

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2025-08-26

Brief Summary

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The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.

Detailed Description

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Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.

Conditions

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Refractive Errors 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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LID023681, then LID006961

Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.

Group Type OTHER

Delefilcon A contact lenses with different base curves and diameters

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Delefilcon A contact lenses with standard base curves and diameters

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

LID006961, then LID023681

Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.

Group Type OTHER

Delefilcon A contact lenses with different base curves and diameters

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Delefilcon A contact lenses with standard base curves and diameters

Intervention Type DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Interventions

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Delefilcon A contact lenses with different base curves and diameters

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Intervention Type DEVICE

Delefilcon A contact lenses with standard base curves and diameters

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Intervention Type DEVICE

Other Intervention Names

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LID023681 DAILIES TOTAL1® LID006961

Eligibility Criteria

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Inclusion Criteria

* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;
* Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);
* Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) 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;
* History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;
* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.
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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Principal Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Kurata Eyecare Center

Los Angeles, California, United States

Site Status

Elsa Pao, OD

Oakland, California, United States

Site Status

Pacific Rims Optometry

San Francisco, California, United States

Site Status

Pearson Research Center, PA

Longwood, Florida, United States

Site Status

Kindred Optics at Maitland Vision

Maitland, Florida, United States

Site Status

Eyeconic Family Eyecare

Dallas, Georgia, United States

Site Status

Dr. Schwartz Optometrist and Associates

Sterling Heights, Michigan, United States

Site Status

Coldwater Vision Research

Coldwater, Mississippi, United States

Site Status

SUNY College of Optometry Clinical Vision Research Center

New York, New York, United States

Site Status

NC Eye Associates, OD, PLLC

Apex, North Carolina, United States

Site Status

See Eye Care Optometry

Charlotte, North Carolina, United States

Site Status

ProCare Vision Centers, Inc.

Granville, Ohio, United States

Site Status

Eyecare Professionals, Inc

Powell, Ohio, United States

Site Status

Wyomissing Optometric Center

Wyomissing, Pennsylvania, United States

Site Status

West Bay Eye Associates

Warwick, Rhode Island, United States

Site Status

Southern College of Optometry

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CLU484-P007

Identifier Type: -

Identifier Source: org_study_id

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