Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

Johnson & Johnson Vision Care, Inc.6 sites in 1 country123 target enrollmentMay 16, 2022

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 123
Locations: 6
Primary Endpoint: Average Daily Wearing Time
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.

Registry

clinicaltrials.gov

Start Date

May 16, 2022

End Date

July 5, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
•Appear able and willing to adhere to the instructions set forth in this clinical protocol.
•Be between 18 and 39 (inclusive) years of age at the time of screening.
•By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable 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.
•Possess a wearable pair of spectacles that provide correction for distance vision.
•The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
•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.
•The best corrected, monocular, distance visual acuity must be 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:
•Be currently pregnant or lactating.
•Be currently using any ocular medications or have any ocular infection of any type.
•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.
•Be currently wearing monovision or multifocal contact lenses.
•Be currently wearing lenses in an extended wear modality.
•Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
•Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
•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 will 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).
•Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

Outcomes

Primary Outcomes

Average Daily Wearing Time

Time Frame: 2-Week Follow-up

Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.

Monocular logMAR Visual Acuity

Time Frame: 2-Week Follow-up

Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.