Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population

Visual Acuity Clinical Trial

Official title:

Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567186
• Other study ID #: CR-6392
• Status: Completed
• Phase: N/A
• Start date: September 6, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: December 2021
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

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

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.

4. Subjects must own a wearable pair of spectacles if required for their distance vision.

5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).

6. The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or, if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix E).

7. The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye.

8. The subject's refractive cylinder must be =0.75 D in each eye.

9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.

10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

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

1. Currently pregnant or lactating.

2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).

5. A history of amblyopia, strabismus or binocular vision abnormality.

6. Use of any of the following medications within 2 weeks prior to enrollment: oral retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids, oral phenothiazines. See section 9.1 for additional details regarding excluded systemic medications.

7. Use of any ocular medication, with the exception of rewetting drops.

8. History of herpetic keratitis.

9. History of irregular cornea.

10. History of pathological dry eye.

11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.

14. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

15. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.

16. Any current ocular infection or inflammation.

17. Any current ocular abnormality that may interfere with contact lens wear.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Investigational senofilcon A C3 Multifocal Lens
TEST
• delefilcon A Multifocal Lens
Dailies Total 1® Multifocal Contact Lens

Locations

Country	Name	City	State
United States	Empire Eye and Laser Center	Bakersfield	California
United States	Stame & Associates, Eye Care	Jacksonville	Florida
United States	VRC-East	Jacksonville	Florida
United States	Spectrum Eyecare	Jamestown	New York
United States	Eye Associates of New York	Manhattan	New York
United States	James R. Dugue, OD	Mission Viejo	California
United States	St. Johns Eye Associates, PA	Saint Augustine	Florida

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	Binocular Visual Acuity (logMAR)	Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.	1-Week Follow-up
Secondary	Subjective Overall Vision Scores	Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft 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. The average CLUE vision score for each lens type was reported.	1- Week Follow-up