Clinical trial NCT05000164: Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens
Official title: Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

Detailed description: The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

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 and not more than 70 years of age at the time of screening.
  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. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past month).
  6. Be an existing wearer of 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".
  7. Have distance spherical component of refraction in the range of either -1.25 D to -3.75 D or +1.25 to +3.75 D in each eye.
  8. Have refractive cylinder in the range of -0.75 D to -1.75 D in each eye, with their cylinder axis 90°±25°.
  9. Have near ADD power requirement in the range of +0.75 D to +2.50 D in each eye.
  10. Have best corrected distance visual acuity of 20/20-3 or better in each eye.

      Exclusion Criteria:
* 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. Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications.
  5. Currently use ocular medication with the exception of rewetting drops.
  6. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, sodium fluorescein, or Biotrue® multipurpose solution.
  7. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  8. Have a history of amblyopia or strabismus.
  9. Have a history of herpetic keratitis.
  10. Have a history of irregular cornea.
  11. Have a history of pathological dry eye.
  12. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  13. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  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 entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
  16. Have any current ocular infection or inflammation.
  17. Have any current ocular abnormality that may interfere with contact lens wear.

Primary outcomes:
measure: Binocular High Luminance High Contrast logMAR Visual Acuity
timeFrame: 4-Week Follow-up
Secondary outcomes:
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: Jacksonville
country: United States
facility: VRC-East
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Decatur
country: United States
facility: The Eyecare Studio
state: Georgia
city: Manhattan
country: United States
facility: Ctr For Opht and Vision Rsrch At Eye Associates Of New York
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Houston
country: United States
facility: Vision Boutique
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: