Clinical trial NCT06967129: Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
Official title: Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.


Eligibility 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 between 18 and 39 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during last 30 days.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
6. In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study:

   1. Sphere powers (DS) -1.50 through -4.00 (inclusive) 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.

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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, Photorefractive Keratectomy \[PRK\], Laser-Assisted in Situ Keratomileusis \[LASIK\], iridotomy, retinal laser photocoagulation, etc.).

Primary outcomes:
measure: Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA)
timeFrame: At each 1-week follow-up per wear period
measure: Toric Lens Orientation
timeFrame: At baseline per wear period
measure: Lens Rotational Stability with Blinks
timeFrame: At baseline per wear period
measure: Percentage of eyes with Grade 3 or higher SLFs relating to the test lens
timeFrame: Up to 3-week follow-up
measure: Percentage of eyes with acceptable lens fitting while wearing the test lens
timeFrame: Up to 3-week follow-up
Secondary outcomes:
measure: Subjective Overall Comfort
timeFrame: At each 1-week follow-up per wear period
measure: Subjective Overall Quality of Vision
timeFrame: At each 1-week follow-up per wear period
measure: Subjective Overall Handling
timeFrame: At each 1-week follow-up per wear period
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: James R. Dugue, Optometrist
state: California
city: San Diego
country: United States
facility: Scripps Poway Eyecare & Optometry
state: California
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 Centers - North Orlando Ave
state: Florida
city: Clinton
country: United States
facility: Mid-State Eye
state: Illinois
city: Franklin Park
country: United States
facility: Franklin Park Eye Center, P.C.
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care - 101 North Broadway
state: Kansas
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Raytown
country: United States
facility: Advanced Eyecare - Raytown, MO
state: Missouri
city: Saint Louis
country: United States
facility: The Koetting Associates
state: Missouri
city: Albuquerque
country: United States
facility: ABQ Eye Care
state: New Mexico
city: Jamestown
country: United States
facility: Spectrum Eye Care
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: Westerville
country: United States
facility: Professional Vision Care Inc. - Westerville
state: Ohio
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
city: Wichita Falls
country: United States
facility: Clarke EyeCare Center
state: Texas
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: