Clinical trial NCT03701516: Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
Official title: Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-10
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.


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. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
  4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
  5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
  7. The subject's refractive cylinder must be \< 0.75 D in each eye.
  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. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
  3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Monovision or multi-focal contact lens correction.
  7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  10. Suspicion of or recent history of alcohol or substance abuse.
  11. History of serious mental illness.
  12. History of seizures.
  13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  14. 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.
  15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale.
  16. 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.

Primary outcomes:
measure: Overall Comfort Scores
timeFrame: 1-week Follow-up
measure: Overall Vision Scores
timeFrame: 1-week Follow-up
Secondary outcomes:
measure: Average Daily Wear Time
timeFrame: 1-week Follow-up
measure: LLHC LogMAR Visual Performance
timeFrame: 1-week Follow-up
measure: HLLC LogMAR Visual Performance
timeFrame: 1-week Follow-up
Other outcomes:
Locations:
city: Rocklin
country: United States
facility: EyeCenter Optometrics
state: California
city: Fleming Island
country: United States
facility: Fleming Island Vision Center
state: Florida
city: Jacksonville
country: United States
facility: Bartram Eye Clinic
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Saint Augustine
country: United States
facility: St. Johns Eye Associates
state: Florida
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: Brentwood
country: United States
facility: Primary Eyecare Group
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Salem
country: United States
facility: Boutetourt Eyecare, LLC
state: Virginia
Study officials:
References: