N/A
Completed N=126
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Source: ClinicalTrials.gov NCT01539694 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Visual Acuity — 0.023; 0.005 logMAR
Summary
The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
0.023; 0.005 | — |
| SECONDARY Symptoms/Complaints |
91.3; 89.2; 87.0; 83.9; 72.5; 68.1 | — |
Eligibility Criteria
Inclusion Criteria
- Have physiologically normal anterior segments.
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
Exclusion Criteria
- Any Grade 2 or greater finding during the slit lamp examination.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study products.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Data sourced from ClinicalTrials.gov (NCT01539694). 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.