Clinical trial NCT04974697: Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
Official title: Evaluation of Daily Disposable Silicone Hydrogel 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: 2021-07-23
Enrollment: 95
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. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational multifocal toric contact 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. worn lenses for at least 8 hours per day at least two days per week for the past 4 weeks).
  6. Be already 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".
  7. The subject's distance spherical component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +3.75 D.
  8. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye, with the cylinder axes in the range of 90°±30°.
  9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  10. The subject must have best corrected distance 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:

  1. Be currently pregnant or lactating.
  2. By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  3. Use systemic medications that may interfere with contact lens wear or cause blurred vision.
  4. Currently use ocular medication (with the exception of rewetting drops).
  5. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
  6. Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).
  7. Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report.
  8. Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  9. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  10. Have a history of amblyopia or strabismus, by self-report.
  11. Have a history of herpetic keratitis, by self-report.
  12. Have ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
  13. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.

Primary outcomes:
measure: Overall Vision
timeFrame: 2-Week Follow-up
measure: LogMAR Visual Acuity
timeFrame: 2-Week Follow-up
Secondary outcomes:
measure: Change From Baseline CLUE Vision Score
timeFrame: Up to 2-Week Follow-up
measure: Change From Baseline CLUE Comfort Score
timeFrame: Up to 2-Week Follow-up
measure: Change From Baseline CLUE Handling Score
timeFrame: Up to 2-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Stam & Associates Eye Care
state: Florida
city: Jacksonville
country: United States
facility: VRC-West
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Bloomfield Township
country: United States
facility: Birmingham Vision Care
state: Michigan
city: New York
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: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: