Clinical trial NCT05222880: Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes
Official title: Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 140
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 is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance.


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".
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:

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 and 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: Binocular logMAR Visual Acuity
timeFrame: 1-Week Follow-up
measure: CLUE Vision Score
timeFrame: 1-Week Follow-up
measure: Proportion of Eyes With Unacceptable Lens Fitting
timeFrame: Up to 1-Week Follow-up
measure: Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
timeFrame: Up to 1-Week Follow-up
Secondary outcomes:
measure: CLUE Vision Score
timeFrame: 1-Week Follow-up
measure: CLUE Comfort Score
timeFrame: 1-Week Follow-up
measure: CLUE Handling Score
timeFrame: 1-Week Follow-up
measure: Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less
timeFrame: Up to 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: Maitland
country: United States
facility: Maitland Vision Center - North Orlando Ave
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
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: Eye Associates of New York
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
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: Houston
country: United States
facility: Vision Optique
state: Texas
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: