Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore

Visual Acuity Clinical Trial

Official title:

Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778786
• Other study ID #: CR-6521
• Status: Completed
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: July 2023
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

The subject must:

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 between 18 and 39 years of age (inclusive) at the time of screening.

4. Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.

5. Possess a wearable pair of spectacles that provide correction for distance vision.

6. In both eyes, have refractive error suitable for correction with the toric contact

lens powers available in this study:

1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps

2. Cylinder powers (DC) -0.75 and -1.25

3. Axes (°) 170, 180, 10, 80, 90, 100

7. Have best corrected monocular distance visual acuity of 20/30 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. Be diabetic.

3. Be currently using any ocular medications or have an ocular infection of any type.

4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.

5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

6. Be currently wearing monovision or multifocal contact lenses.

7. Be currently wearing lenses in an extended wear modality.

8. Have a history of strabismus or amblyopia.

9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.

11. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).

12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Acuvue Oasys 1 Day for Astigmatism
CONTROL
• TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
TEST

Locations

Country	Name	City	State
United States	ProCare Vision Centers	Granville	Ohio
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	Complete Eye Care of Medina	Medina	Minnesota
United States	Optometry Group, LLC	Memphis	Tennessee
United States	Botetourt Eyecare, LLC	Salem	Virginia
United States	Tyler Eye Associates	Tyler	Texas
United States	Sacco Eye Group	Vestal	New York
United States	Professional Vision Care Inc. - Westerville	Westerville	Ohio

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	Slit Lamp Findings (SLF)	SLFs (Grade 3 or higher) related to study lens wear will be assessed for each eye at all study visits. SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings.	At the 1 week follow up
Primary	Acceptable Lens Fit	Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Lens fit will be deemed unacceptable if any one of the following criteria are met: limbal exposure at primary gaze or with extreme eye movement; edge lift; excessive movement in primary up gaze; insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.	At the 1 week follow up
Primary	Visual Acuity (logMAR)	Visual acuity (VA) will be measured monocularly at the 1-week follow-up evaluation under high-contrast (HLHC) (>400 lux, 120 - 200 cd/m2) conditions at a test distance of 4 meters.	At the 1 week follow up
Primary	Toric Lens Orientation Absolute lens orientation	Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at least 15 minutes after lens insertion.	15 minutes after lens insertion
Primary	Rotation Stability with blinks	Rotational stability with blinks will be assessed for each eye at least 15 minutes after lens insertion.	15 minutes after lens insertion
Primary	Subjective Vision	Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens.	At the 1 week follow up
Secondary	CLUE Handling score	CLUE handling score will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens.	At the 1 week follow up
Secondary	CLUE Comfort score	CLUE comfort score will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens.	At the 1 week follow up