N/A
Completed N=322
Evaluation of an Investigational Multifocal Lens
Source: ClinicalTrials.gov NCT02223754 ↗Enrolled (actual)
322
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire — 51.15; 54.28; 53.55; 51.84 units on a scale
Summary
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire |
51.15; 54.28; 53.55; 51.84 | — |
| PRIMARY Distance Binocular Visual Acuity (LogMAR) |
-0.069; -0.066; -0.100; -0.093 | — |
| PRIMARY Intermediate Binocular Visual Acuity (LogMAR) |
-0.061; -0.050; -0.081; -0.063 | — |
| PRIMARY Near Binocular Visual Acuity (LogMAR) |
0.050; 0.074; 0.034; 0.049 | — |
| PRIMARY Corneal Staining |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Bulbar Conjunctival Injection |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Limbal Conjunctival Injection |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Contact Lens Fitting |
100; 100; 99.5; 100 | — |
Eligibility Criteria
Inclusion Criteria
- The subjects were required to have read, understand, and signed 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.
- Between 40 and 70 years of age.
- Subjects must own a wearable pair of spectacles, if required for their distance vision.
- 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 of more duration)
- 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"*
- The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
- Refractive cylinder ≤ -0.75 D in each eye.
- ADD power in the range +0.75 D to +2.50 D in each eye.
- Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria
- Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
- Any ocular or systemic allergies that may have contraindicated contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
- Any ocular abnormality that may have interfered 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.).
- History of herpetic keratitis.
- 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.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- 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.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
Data sourced from ClinicalTrials.gov (NCT02223754). 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. Informational only — not medical advice.