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COMPLETEDNA

Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)

Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

NCT05480514•Johnson & Johnson Vision Care, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to evaluate visual acuity.

Eligibility

Age

18 - 29 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
•2. Females between 18 and 29 (inclusive) years of age at the time of screening
•3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
•4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report
•5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report
•6. The subject must be willing to be photographed and/or video-taped
•7. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye
•8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
•9. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•1. Currently pregnant or lactating
•2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion)
•3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
•4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.)
•5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).
•6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
•7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician)
•8. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion)
•9. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

Locations (2)

Vital Eyecare Center Limited

Mong Kok, Kowloon, Hong Kong

Sight Enhancement Center

Yau Ma Tei, Kowloon, Hong Kong

Key Dates

Start Date

August 27, 2022

Primary Completion Date

November 16, 2022

Completion Date

November 16, 2022

Last Updated

January 3, 2024

Enrollment

ACTUAL participants

Conditions

Visual Acuity

Interventions

TEST LENS

DEVICE

CONTROL LENS

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)

Inclusion Criteria

Exclusion Criteria

Effect of Action Video Games and Stroboscopic Glasses on Dynamic Visual Acuity.

Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

Assessing the Turkish DDIVAT for Visual Acuity Measurement

Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements

Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

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