Clinical trial NCT03322423: Evaluation of Two Marketed Multifocal Contact Lenses
Official title: Evaluation of Two Marketed Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Performance
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-26
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.


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. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between at least 40 years of age and not greater than 70 years of age.
  4. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
  5. The subject's refractive cylinder must be ≤ -0.75 D in each eye.
  6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
  8. The subject must own a pair of wearable spectacles if required for their distance vision.
  9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
  10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

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

  1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
  2. Pregnancy or lactation.
  3. Currently diagnosed with diabetes.
  4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
  5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
  7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  8. A history of amblyopia, strabismus or binocular vision abnormality.
  9. Any ocular infection or inflammation.
  10. Any ocular abnormality that may interfere with contact lens wear.
  11. Use of any ocular medication, with the exception of rewetting drops.
  12. History of herpetic keratitis.
  13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Primary outcomes:
measure: Distance Binocular Visual Acuity
timeFrame: 1-Week Follow-up
measure: Near Binocular Visual Acuity
timeFrame: 1-Week Follow-up
Secondary outcomes:
measure: Overall Quality of Vision
timeFrame: 1-Week Follow-up
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
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: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Salem
country: United States
facility: Botetourt Eyecare, LLC
state: Virginia
Study officials:
References: