Clinical trial NCT05258149: Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product
Official title: Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 143
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, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision.


Eligibility criteria: Inclusion Criteria:

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

  1. 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. Be at least 40 years of age and not greater than 70 years of age at the time of consent.
  4. Own a wearable pair of spectacles if required for their distance vision.
  5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
  6. Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix D).
  7. The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 D in each eye.
  8. The subject's refractive cylinder must be ≤0.75 D in each eye.
  9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
  10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

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

The subject must not:

1. Be currently pregnant or lactating.
2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
3. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
4. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
5. Have a history of amblyopia, strabismus or binocular vision abnormality.
6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
7. Use of any ocular medication, with the exception of rewetting drops.
8. Have a history of herpetic keratitis.
9. Have a history of irregular cornea.
10. Have a history of pathological dry eye.
11. Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
12. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
13. Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
14. Have clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
15. Have any current ocular infection or inflammation.
16. Have any current ocular abnormality that may interfere with contact lens wear.

Primary outcomes:
measure: Clarity of Vision in Dim or Low Lighting
timeFrame: 1-Week Follow-up
measure: Clarity of Vision When Reading in Dim Light
timeFrame: 1-Week Follow-up
Secondary outcomes:
measure: Clarity of Distance Vision
timeFrame: 1-Week Follow-up
measure: Clarity of Intermediate Vision
timeFrame: 1-Week Follow-up
measure: Clarity of Near Vision
timeFrame: 1-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Jacksonville
country: United States
facility: Stam & Associates Eye Care
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: Roswell
country: United States
facility: VisualEyes
state: Georgia
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Jamestown
country: United States
facility: Spectrum Eyecare
state: New York
city: Manhattan
country: United States
facility: Eye Associates of New York
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Centers
state: Ohio
city: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
city: Salem
country: United States
facility: Botetourt Eyecare, LLC
state: Virginia
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: