Clinical Performance of Senofilcon A Investigational Lens

Not Applicable

Completed

• Conditions: Visual Acuity
• Interventions: Device: senofilcon A prototype; Device: Dailies Total 1

• Registration Number: NCT05300763
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study Start: 2022-03-21
• Study First Posted: 2022-03-29
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Results First Submitted: 2023-05-09
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Results First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

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.

   Inclusion Criteria at Baseline Evaluation

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.

9. The best corrected, monocular, distance visual acuity must be 20/25or better in each eye.

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study: Exclusion Criteria after Screening

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.

8. 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. Exclusion Criteria at Baseline Evaluation

   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).

10. Have a history of strabismus or amblyopia.

11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEST LENS	senofilcon A prototype	Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the TEST Lens for the duration of the study.
CONTROL LENS	Dailies Total 1	Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the CONTROL Lens for the duration of the study.

Primary Outcome Measures

Name	Time	Method
End of Day Comfort	2-Week Follow-up	End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.

Secondary Outcome Measures

Name	Time	Method
Comfortable Vision While Night Driving	2-Week Follow-up	Comfortable vision while night driving was assessed using an individual item "Ability to see comfortably while driving at night". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.
Digital Device Use	2-Week Follow-up	Lens performance in digital device use was assessed using an individual item "Reduction in the feeling of tired eyes from using a computer or other digital device". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.
Comfort Throughout the Day	2-Week Follow-up	Comfort throughout the day was measured using an individual item "I could wear these contact lenses comfortably for as long as I wanted to". Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree.

Trial Locations

Locations (19)

Vue Optical Boutique; 🇺🇸 Jacksonville, Florida, United States

Dr. James Weber & Associates, PA - City Square Blvd; 🇺🇸 Jacksonville, Florida, United States

Flora Chen Poveda, OD, PA - Orange Park; 🇺🇸 Orange Park, Florida, United States

Sabal Eye Care; 🇺🇸 Longwood, Florida, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Randall Go, OD; 🇺🇸 San Francisco, California, United States

Stam & Associates Eye Care; 🇺🇸 Jacksonville, Florida, United States

Maitland Vision Center - North Orlando Ave; 🇺🇸 Maitland, Florida, United States

Southwest Orlando Eye Care; 🇺🇸 Orlando, Florida, United States

VisualEyes; 🇺🇸 Roswell, Georgia, United States

Tallahassee Eye Center; 🇺🇸 Tallahassee, Florida, United States

Birmingham Vision Care; 🇺🇸 Bloomfield, Michigan, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

Dr. David W. Ferris & Associates; 🇺🇸 Warwick, Rhode Island, United States

ProCare Vision Centers; 🇺🇸 Granville, Ohio, United States

Optometry Group, LLC; 🇺🇸 Memphis, Tennessee, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States

Tyler Eye Associates; 🇺🇸 Tyler, Texas, United States

Botetourt Eyecare, LLC; 🇺🇸 Salem, Virginia, United States