Clinical trial NCT06377488: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
Official title: Evaluation of the Clinical Performance 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: 2024-04-22
Enrollment: 176
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: This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.


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 +4.25 D.
8. The subject's refractive cylinder must be in the range of -1.00 D to -1.75 D in each eye, with the cylinder axes in the range of either 90°±15° or 180°±15°.
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:

The subject must not:

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, 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. See Section 9.1 for additional details regarding excluded systemic medications.
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: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m
timeFrame: at 2-week follow-up
measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm
timeFrame: at 2-week follow-up
measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm
timeFrame: at 2-week follow-up
measure: Subjective Vision CLUE Scores
timeFrame: at 2-week follow-up
measure: Rotational Stability
timeFrame: at least 15-minutes after lens insertion at fitting visit
measure: Absolute Rotation Error
timeFrame: at least 15-minutes after lens insertion at fitting visit
measure: Incidence of Unacceptable Lens Fit
timeFrame: up to 2-week follow-up
measure: Slit Lamp Findings
timeFrame: up to 2-week follow-up
Secondary outcomes:
measure: Subjective Handling Scores
timeFrame: at 2-week follow-up
measure: Subjective Comfort Scores
timeFrame: at 2-week follow-up
measure: Subjective Vision Scores
timeFrame: at 2-week follow-up
measure: Lens Fit Success
timeFrame: up to 1-week follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates, PA - City Square Blvd
state: Florida
city: Jacksonville
country: United States
facility: Stam & Associates Eye Care
state: Florida
city: Longwood
country: United States
facility: Omega Vision Center
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center - North Orlando Ave
state: Florida
city: Clinton
country: United States
facility: Mid-State Eye
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Bloomfield Hills
country: United States
facility: Birmingham Vision Care
state: Michigan
city: Manhattan
country: United States
facility: Center for Ophthalmic and Vision Research/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: Powell
country: United States
facility: Luxe Vision and Optical
state: Ohio
city: Warwick
country: United States
facility: Dr. David W. Ferris & Associates
state: Rhode Island
city: Memphis
country: United States
facility: Optometry Group, LLC
state: Tennessee
city: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
city: Oak Hill
country: United States
facility: New River Vision Care
state: West Virginia
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: