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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04889625
Other study ID # CR-6444
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2021
Est. completion date July 21, 2021

Study information

Verified date June 2022
Source Johnson & Johnson Vision Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-masked, 2×3 crossover, randomized controlled, dispensing clinical trial to evaluate the visual performance (logMAR) and subjective vision responses of the Test Lens.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date July 21, 2021
Est. primary completion date July 21, 2021
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, diabetes, 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 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples. 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 3 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. Any current ocular infection or inflammation. 16. Any current ocular abnormality that may interfere with contact lens wear.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
senofilcon A C3
Test Lens
Dailies Total 1® Multifocal Contact Lenses
Control Lens

Locations

Country Name City State
United States Procare Vision Centers Granville Ohio
United States Gulf Coast Vision Center Houston Texas
United States Vue Optical Boutique Jacksonville Florida
United States St. Johns Eye Associates Saint Augustine Florida
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 Visual Acuity Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast (HLHC) lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 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 (64cm) 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 Overall Vision Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience 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. 1-Week Follow-up
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