Clinical trial NCT03208088: Clinical Evaluation of Multifocal Toric Contact Lenses
Official title: Clinical Evaluation of Multifocal Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 96
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 double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.


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 40 and 70 years of age.
  4. The subject's distance refraction must be in the range of -1.50 D to -4.50 D.
  5. The subject's refractive cylinder must be -1.00 to -1.50 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. Subjects must own a wearable pair of spectacles if required for their distance vision
  9. The subject must be an adapted soft contact lens wearer in both eyes (ie, 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 already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the "Presbyopic Systems Questionnaire".

Exclusion Criteria:

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 (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, 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 (eg, 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 (eg, Investigator, Coordinator, Technician).

Primary outcomes:
measure: Overall Handling Comparison Between Test 1/Test 2 and Control
timeFrame: 15 minutes
Secondary outcomes:
measure: Overall Handling Comparison Between Test 3/Test 4 and Control
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Orlando
country: United States
facility: Bay Hill Eye Care
state: Florida
city: Kahului
country: United States
facility: Lee & Leong Doctors of Optometry
state: Hawaii
city: Jamestown
country: United States
facility: Spectrum Eyecare
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Miamisburg
country: United States
facility: Miamisburg Vision Care
state: Ohio
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
References: