N/A
N=30
Marketed Contact Lens Real World Through Focus Curve
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT02679976 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Distance Binocular LogMAR Visual Acuity — -1.072; -0.904; 0.9017; 0.557 -10*LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon A (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Binocular LogMAR Visual Acuity |
-1.072; -0.904; 0.9017; 0.557; 1.488; 1.471 | — |
| PRIMARY Near Binocular LogMAR Visual Acuity |
-2.278; -2.261; -0.591; -0.650; 0.828; 0.786 | — |
| PRIMARY Intermediate Binocular LogMAR Visual Acuity |
-1.544; -1.318; -0.075; 0.043; 1.056; 1.157 | — |
Summary
This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.
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 ≥40 years of age.
- The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
- 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 to +2.50 D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better for each eye.
- The subject can be either a new contact lens wearer or an existing soft contact lens wearer.
Exclusion Criteria
- Currently pregnant or lactating.
- 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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and 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.
- Participant in unrelated research involving test product within 30 days before planned study visit.
Data sourced from ClinicalTrials.gov (NCT02679976). 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.