N/A
N=108
Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
Vision Correction
Bottom Line
View on ClinicalTrials.gov: NCT02394925 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Proportion of Successful Contact Lens Wearers — 0.71 Proportion of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multifocal Test Contact lens (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Successful Contact Lens Wearers |
0.71 | — |
Summary
The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.
Eligibility Criteria
Inclusion Criteria
- 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 40 and 70 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
- The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies that contraindicate contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- History of herpetic keratitis.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
- History of diabetes.
- Current or previous history of being prescribed a correction for distance vision.
- Current or previous history of contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT02394925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.