Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

Visual Acuity Clinical Trial

Official title:

Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377488
• Other study ID #: CR-6542
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: June 24, 2024

Study information

• Verified date: April 2024
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: Study Contact
• Phone: 1-800-843-2020
• Email: rfrankl1[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 155
• Est. completion date: June 24, 2024
• Est. primary completion date: June 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter
Test Lens

Locations

Country	Name	City	State
United States	Birmingham Vision Care	Bloomfield Hills	Michigan
United States	Mid-State Eye	Clinton	Illinois
United States	ProCare Vision Centers	Granville	Ohio
United States	Dr. James Weber & Associates, PA - City Square Blvd	Jacksonville	Florida
United States	Stam & Associates Eye Care	Jacksonville	Florida
United States	Omega Vision Center	Longwood	Florida
United States	Maitland Vision Center - North Orlando Ave	Maitland	Florida
United States	Center for Ophthalmic and Vision Research/Eye Associates of New York	Manhattan	New York
United States	Optometry Group, LLC	Memphis	Tennessee
United States	New River Vision Care	Oak Hill	West Virginia
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Luxe Vision and Optical	Powell	Ohio
United States	Tyler Eye Associates	Tyler	Texas
United States	Sacco Eye Group	Vestal	New York
United States	Dr. David W. Ferris & Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m	Binocular visual acuity at the 2-week follow-up with the optimized lens pair using high contrast letters in high luminance (120 - 200 cd/m2) and bright illuminance (>400 lux) conditions will be measured at distance (4 meters) using ETDRS Charts .	at 2-week follow-up
Primary	High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm	Binocular visual acuity at the 2-week follow-up with the optimized lens pair using high contrast letters in high luminance (225 - 275 cd/m2) and bright illuminance (>400 lux) conditions will be measured at intermediate distance (64 centimeters) using reduced Guillon-Poling charts.	at 2-week follow-up
Primary	High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm	Binocular visual acuity at the 2-week follow-up with the optimized lens pair using high contrast letters in high luminance (225 - 275 cd/m2) and bright illuminance (>400 lux) conditions will be measured at near distance (40 centimeters) using reduced Guillon-Poling charts.	at 2-week follow-up
Primary	Subjective Vision CLUE Scores	Subjective vision scores will be assessed using the Contact Lens User Experience (CLUE) questionnaire at the 2-week follow-up in the optimized lens pair. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE™ scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	at 2-week follow-up
Primary	Rotational Stability	Rotational stability with blink will be assessed at least 15 minutes after lens insertion at the dispensing visit (Visit 1). Rotational stability is amount of observed rotational movement of the lens' scribe markings in degrees that occurs while blinking in primary gaze.	at least 15-minutes after lens insertion at fitting visit
Primary	Absolute Rotation Error	Absolute rotation error will be assessed at least 15 minutes after lens insertion at the dispensing visit (Visit 1). Absolute rotation error is quantified by the absolute value of mis-location of the lens' scribe markings in degrees relative to a vertical reference line.	at least 15-minutes after lens insertion at fitting visit
Primary	Incidence of Unacceptable Lens Fit	Incidence (percentage) of eyes with unacceptable fitting will be measured at any time during the study. Lens fit is defined as "unacceptable" if any one of the following criteria is met: limbal exposure at primary gaze or with extreme eye movement; edge lift; excessive movement in primary gaze; insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.	up to 2-week follow-up
Primary	Slit Lamp Findings	Slit Lamp Findings will be assessed for each subject eye at all study visits (scheduled and unscheduled). SLFs will be evaluated and classified using the FDA Grading scale rating from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1=trace, Grade 2=mild, Grade 3=moderate and Grade 4=severe). Eyes with multiple SL findings of Grade=3 at different timepoint during the visit, or with different grade level over time, will be counted only once.	up to 2-week follow-up
Secondary	Subjective Handling Scores	Subjective Handling Scores will be assessed using the CLUE questionnaire at the 2-week follow-up. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE™ scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	at 2-week follow-up
Secondary	Subjective Comfort Scores	Subjective Comfort Scores will be assessed using the CLUE questionnaire at the 2-week follow-up. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE™ scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	at 2-week follow-up
Secondary	Subjective Vision Scores	Subjective Vision Scores will be assessed using the CLUE questionnaire at the 2-week follow-up. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE™ scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	at 2-week follow-up
Secondary	Lens Fit Success	Lens Fit Success is the number of lenses needed to fit (optimize) the subject's vision. The number of lenses needed is determined using lens selection data from both Visit 1 and Visit 2 .	up to 1-week follow-up