Clinical trial NCT03466060: Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
Official title: Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.


Eligibility criteria: Inclusion Criteria:

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

  1. Subjects must be 18-69 years of age (inclusive).
  2. Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
  3. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
  4. The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
  5. The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
  6. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  7. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
  8. Subjects must read, understand, and sign the Statement of Informed Consent.
  9. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or breast-feeding.
  2. Diabetes
  3. Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
  4. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
  5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
  6. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
  7. Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
  8. Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
  9. Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
  10. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
  11. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
  12. History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
  13. Habitual contact lens wear modality as extended wear.
  14. Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
  15. History of binocular vision abnormality or strabismus.
  16. Habitual wearers of rigid gas permeable lens within the past 3 months.
  17. Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report

Primary outcomes:
measure: Subject Comfort
timeFrame: Up to 2-Hours Post Lens Fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Southern California College of Optometry
state: California
city: Berkeley
country: United States
facility: University of California, Berkeley School of Optometry
state: California
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
References: