Clinical trial NCT03742271: Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population
Official title: Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.


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 39 (inclusive) years of age at the time of screening.
  4. They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
  5. Habitual spectacles must have resulted from an eye exam within the past six months.
  6. The subject must have worn the updated spectacles for at least two weeks.
  7. Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
  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 -1.00 D or less in each eye.
  10. Have spherocylindrical best corrected distance Snellen 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

  1. Currently pregnant or lactating.
  2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  3. Use of systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).
  4. Any current use of ocular medication.
  5. Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.
  6. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  7. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  8. 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.
  9. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.
  10. Binocular vision abnormality or strabismus.

Primary outcomes:
measure: Acceptable Lens Fitting
timeFrame: 4-Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville Beach
country: United States
facility: Atlantic Eye Institute
state: Florida
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Macclenny
country: United States
facility: Baker Vision Care
state: Florida
city: Greensboro
country: United States
facility: Georgia Center for Sight
state: Georgia
city: Raytown
country: United States
facility: Advanced Eyecare
state: Missouri
city: Albuquerque
country: United States
facility: ABQ Eye Care
state: New Mexico
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Centers
state: Ohio
city: Powell
country: United States
facility: Eyecare Professionals of Powell
state: Ohio
city: Tyler
country: United States
facility: Frazier Vision Inc.
state: Texas
Study officials:
References: