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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05778786

CR-6521

Details and patient eligibility

About

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

Enrollment: 188 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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188 participants in 2 patient groups

Test/Control

Experimental group

Description:

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (test then control) with a washout period of 7+/-2 days duration between wear periods.

Treatment:

Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore

Device: Acuvue Oasys 1 Day for Astigmatism

Control/Test

Experimental group

Description:

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (control then test) with a washout period of 7+/-2 days duration between wear periods.

Treatment:

Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore

Device: Acuvue Oasys 1 Day for Astigmatism