Clinical trial NCT05099380: Validation of Senofilcon A With New UV / HEV Filter
Official title: Validation of Senofilcon A With New UV / HEV Filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 296
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 is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  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 silicone hydrogel soft 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.
  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. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes.
  7. The subject's refractive cylinder must be 1.00 D or less.
  8. The subject must have best corrected visual acuity of 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:

  1. Be currently pregnant or lactating.
  2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
  4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  5. Be currently wearing lenses in a monovision, multifocal, toric, or extended wear modality.
  6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment
  7. 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.
  8. Have a history of binocular vision abnormality or strabismus.
  9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

  11. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

  13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

Primary outcomes:
measure: Overall Quality of Vision Score
timeFrame: 2-Week Follow-up
measure: Distance Monocular logMAR Visual Acuity
timeFrame: 2-Week Follow-up
measure: Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
timeFrame: up to 2-week follow-up
measure: Proportion of Eyes With Unacceptable Lens Fitting
timeFrame: Up to 2-Week Follow-up
Secondary outcomes:
measure: Overall Comfort Scores
timeFrame: 2-Week Follow-up
measure: Overall Handling Scores
timeFrame: 2-Week Follow-up
measure: Situational Visual Performance - Indoors
timeFrame: 2-Week Follow-up
measure: Situational Visual Performance - Digital Devices
timeFrame: 2-Week Follow-up
Other outcomes:
Locations:
city: Cupertino
country: United States
facility: James T. Fujimoto, O.D.
state: California
city: San Francisco
country: United States
facility: Randall Go, OD
state: California
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates, PA
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Orange Park
country: United States
facility: Flora Chen Poveda, OD, PA
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Roswell
country: United States
facility: VisualEyes, Inc
state: Georgia
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Bloomfield Township
country: United States
facility: Birmingham Vision Care
state: Michigan
city: Closter
country: United States
facility: Dr. Debbie H. Kim, OD
state: New Jersey
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Westerville
country: United States
facility: Professional Vision Care, Inc.
state: Ohio
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Brentwood
country: United States
facility: Primary Eyecare Group
state: Tennessee
city: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
city: Salt Lake City
country: United States
facility: William J. Bogus, OD, FAAO
state: Utah
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: