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Clinical Performance of Senofilcon A Investigational Lens | Clinical Trials | Clareo Health

COMPLETEDNA

Clinical Performance of Senofilcon A Investigational Lens

NCT05300763•Johnson & Johnson Vision Care, Inc.

Summary

This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.

Eligibility

Age

18 - 39 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•The subject must:
•1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
•2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
•3. Be between 18 and 39 (inclusive) years of age at the time of screening.
•4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily wear or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
•5. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
•6. Possess a wearable pair of spectacles that provide correction for distance vision.
•7. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
•8. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
+1 more criteria

Exclusion Criteria

•The subject must not:
•1. Be currently pregnant or lactating.
•2. Be currently using any ocular medications or have any ocular infection of any type.
•3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
•4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
•5. Be currently wearing monovision or multifocal contact lenses.
•6. Be currently wearing lenses in an extended wear modality.
•7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
•The subject must not:
•9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed).
+3 more criteria

Locations (19)

Randall Go, OD

San Francisco, California, United States

Vue Optical Boutique

Jacksonville, Florida, United States

Dr. James Weber & Associates, PA - City Square Blvd

Jacksonville, Florida, United States

Stam & Associates Eye Care

Jacksonville, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Flora Chen Poveda, OD, PA - Orange Park

Orange Park, Florida, United States

Southwest Orlando Eye Care

Orlando, Florida, United States

Tallahassee Eye Center

Tallahassee, Florida, United States

VisualEyes

Roswell, Georgia, United States

Key Dates

Start Date

March 21, 2022

Primary Completion Date

May 25, 2022

Completion Date

May 25, 2022

Last Updated

June 22, 2023

Enrollment

344

ACTUAL participants

Conditions

Visual Acuity

Interventions

senofilcon A prototype

DEVICE

Dailies Total 1

DEVICE

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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: June 22, 2023Data 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 Performance of Senofilcon A Investigational Lens

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

Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults