Clinical trial NCT05300763: Clinical Performance of Senofilcon A Investigational Lens
Official title: Clinical Performance of Senofilcon A Investigational Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: End of Day Comfort
timeFrame: 2-Week Follow-up
Secondary outcomes:
measure: Digital Device Use
timeFrame: 2-Week Follow-up
measure: Comfort Throughout the Day
timeFrame: 2-Week Follow-up
measure: Comfortable Vision While Night Driving
timeFrame: 2-Week Follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Randall Go, OD
state: California
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates, PA - City Square Blvd
state: Florida
city: Jacksonville
country: United States
facility: Stam & Associates Eye Care
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center - North Orlando Ave
state: Florida
city: Orange Park
country: United States
facility: Flora Chen Poveda, OD, PA - Orange Park
state: Florida
city: Orlando
country: United States
facility: Southwest Orlando Eye Care
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Roswell
country: United States
facility: VisualEyes
state: Georgia
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Bloomfield
country: United States
facility: Birmingham Vision Care
state: Michigan
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Centers
state: Ohio
city: Warwick
country: United States
facility: Dr. David W. Ferris & Associates
state: Rhode Island
city: Memphis
country: United States
facility: Optometry Group, LLC
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
city: Salem
country: United States
facility: Botetourt Eyecare, LLC
state: Virginia
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: