Status:
COMPLETED
Evaluation of Two Marketed Multifocal Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Performance
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between at least 40 years of age and not greater than 70 years of age.
- The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
- The subject's refractive cylinder must be ≤ -0.75 D in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- The subject must own a pair of wearable spectacles if required for their distance vision.
- 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).
- 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
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- Pregnancy or lactation.
- Currently diagnosed with diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- 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.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
- Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
- Any ocular infection or inflammation.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- History of herpetic keratitis.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Employee of clinical site (e.g., Investigator, Coordinator, Technician)
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2017
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03322423
Start Date
September 11 2017
End Date
November 4 2017
Last Update
January 8 2019
Active Locations (5)
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1
Golden Vision
Sarasota, Florida, United States, 34232
2
ABQ Eye Care
Albuquerque, New Mexico, United States, 87109
3
Sacco Eye Group
Vestal, New York, United States, 13850
4
West Bay Eye Associates
Warwick, Rhode Island, United States, 02888