Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
Purpose
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.
Condition
- Astigmatism
Eligibility
- Eligible Ages
- Between 18 Years and 39 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Test/Control |
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods. |
|
Experimental Control/Test |
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods. |
|
Recruiting Locations
Mission Viejo, California 92691
San Diego, California 92131
Jacksonville, Florida 32256
Longwood, Florida 32779
Maitland, Florida 32751
Clinton, Illinois 61727
Franklin Park, Illinois 60131
Pittsburg, Kansas 66762
Medina, Minnesota 55340
Raytown, Missouri 64133
Saint Louis, Missouri 63144
Albuquerque, New Mexico 87109
Jamestown, New York 14750
Vestal, New York 13850
Granville, Ohio 43023
Westerville, Ohio 43081
Memphis, Tennessee 38111
Memphis, Tennessee 38119
Tyler, Texas 75703
Wichita Falls, Texas 76308
More Details
- NCT ID
- NCT06967129
- Status
- Recruiting
- Sponsor
- Johnson & Johnson Vision Care, Inc.