Evaluation of Two Marketed Multifocal Contact Lenses

Visual Performance Clinical Trial

Official title:

Evaluation of Two Marketed Multifocal Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322423
• Other study ID #: CR-5860
• Status: Completed
• Phase: N/A
• Start date: September 11, 2017
• Est. completion date: November 4, 2017

Study information

• Verified date: December 2018
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 4, 2017
• Est. primary completion date: November 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Potential subjects must satisfy all of 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 between at least 40 years of age and not greater than 70 years of age.

4. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.

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

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

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

8. The subject must own a pair of wearable spectacles if required for their distance vision.

9. 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 8 hours per wear day, for 1 month or more duration).

10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

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

1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.

2. Pregnancy or lactation.

3. Currently diagnosed with diabetes.

4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).

5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

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

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

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

9. Any ocular infection or inflammation.

10. Any ocular abnormality that may interfere with contact lens wear.

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

12. History of herpetic keratitis.

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

14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Related Conditions & MeSH terms

• Visual Performance

Intervention

Device:
• Multifocal Contact Lens 1
Dailies Total 1 Multifocal Contact Lens
• Multifocal Contact Lens 2
Biotrue ONEday for Presbyopia Contact Lenses
• Spherical Contact Lens 2
BioTrue ONEDay Spherical

Locations

Country	Name	City	State
United States	ABQ Eye Care	Albuquerque	New Mexico
United States	Botetourt Eyecare, LLC	Salem	Virginia
United States	Golden Vision	Sarasota	Florida
United States	Sacco Eye Group	Vestal	New York
United States	West Bay Eye Associates	Warwick	Rhode Island

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	Distance Binocular Visual Acuity	Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.	1-Week Follow-up
Primary	Near Binocular Visual Acuity	Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.	1-Week Follow-up
Secondary	Overall Quality of Vision	Overall quality of vision was 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