Clinical trial NCT03707821: Design Validation of Senofilcon A With New UV-blocking Additive
Official title: Design Validation of Senofilcon A With New UV-blocking Additive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.


Eligibility criteria: Inclusion Criteria:

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

  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. Between 18 and 49 (inclusive) years of age at the time of informed consent.
  4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
  5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
  6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
  7. Subjects must own a wearable pair of distance spectacles.
  8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
  9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.
  10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 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. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
  3. Subjects taking suspect oral medications for less than one year.
  4. Any prescribed or over the counter (OTC) ocular medication.
  5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
  6. Toric, extended wear, monovision or multi-focal contact lens correction.
  7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
  8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
  10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  11. Binocular vision abnormality or strabismus by self-report or prior medical history.
  12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
  13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
  14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
  15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

Primary outcomes:
measure: Overall Comfort Score
timeFrame: 2-Week Follow-up Evlauation
measure: Vision Satisfaction in Bright Lighting
timeFrame: 2-Week Follow-up Evaluation
measure: Distance Visual Acuity
timeFrame: 2-Week Follow-up Evlauation
measure: Contact Lens Fitting Acceptance Rate
timeFrame: Up to 2-Week Follow-up
measure: Number of Grade 3 or Higher Slit Lamp Findings
timeFrame: Up to 2-Week Follow-up Evlauation
Secondary outcomes:
measure: Overall Handling Score
timeFrame: 2-Week Follow-up Evlauation
measure: Overall Quality of Vision Score
timeFrame: 2-Week Follow-up Evlauation
Other outcomes:
Locations:
city: Cupertino
country: United States
facility: James T. Fujimoto, OD
state: California
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Bloomington
country: United States
facility: Eyecare Associates LLP
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Granville
country: United States
facility: ProCare Vision Centers
state: Ohio
city: Westerville
country: United States
facility: Professional Vision Care, Inc
state: Ohio
city: Memphis
country: United States
facility: Bradley Hines, OD
state: Tennessee
city: Tyler
country: United States
facility: Frazier Vision, Inc
state: Texas
city: New Berlin
country: United States
facility: Ziegler Leffingwell Eyecare
state: Wisconsin
Study officials:
References: