Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process

Ocular Physiology Clinical Trial

Official title:

Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427539
• Other study ID #: CR-6482
• Status: Completed
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: September 30, 2022

Study information

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

Clinical Trial Summary

This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence × 2-period crossover study to evaluate ocular physiology following approximately one week of contact lens wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• 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 (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 the past month.

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.

Exclusion Criteria:

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

The submit 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

• Ocular Physiology

Intervention

Device:
• TEST LENS
AO1DfA manufactured with PG hydration
• CONTROL LENS
AO1DfA manufactured with IPA hydration

Locations

Country	Name	City	State
United States	VRC	Jacksonville	Florida
United States	Maitland Vision Center - North Orlando Ave	Maitland	Florida
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

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	Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings	Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported.	Up to 1-Week Follow-up