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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531241
• Other study ID #: CR-6417
• Status: Completed
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: November 2021
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. The subject must 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. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.

4. The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear).

5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

6. The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye.

7. The subject's refractive cylinder must be =0.75D in each eye, if present

8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator)

3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

4. Any ocular infection.

5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

6. Monovision or multi-focal contact lens correction.

7. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

8. History of binocular vision abnormality or strabismus.

9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).

10. Suspicion of or recent history of alcohol or substance abuse.

11. History of serious mental illness.

12. History of seizures.

13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)

14. 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

15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• ACUVUE® OASYS 1-DAY
senofilcon A contact lenses made with a novel manufacturing technology
• ACUVUE® OASYS 1-DAY
senofilcon A contact lenses made with the current manufacturing technology

Locations

Country	Name	City	State
United States	VisionPoint Eye Center	Bloomington	Illinois
United States	ProCare Vision Centers	Granville	Ohio
United States	Vue Optical Boutique	Jacksonville	Florida
United States	Maitland Vision Center	Maitland	Florida
United States	EyeCare Professionals of Powell	Powell	Ohio
United States	Tallahassee Eye Center	Tallahassee	Florida
United States	Frazier Vision, Inc.	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall CLUE Comfort	Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	1-Week Follow-up
Primary	Overall CLUE Vision	Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	1-Week Follow-up
Secondary	Visual Performance	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under both high luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For high illumination, the room was required to be >400 lux with low contrast charts. For low illumination, the room was required to be <2.5 lux. 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.	1-Week Follow-up
Secondary	Average Daily Wear Time (in Hours)	Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow up evaluation.	1-Week Follow-up