N/A
Completed N=17
Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
Refractive Ametropia
Source: ClinicalTrials.gov NCT05765227 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) — -0.08; -0.06 logMAR
Summary
The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) |
-0.08; -0.06 | — |
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
- Willing to stop wearing habitual contact lenses for the duration of study participation;
- Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
- History of refractive surgery, or plan to have refractive surgery during the study;
- Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
- Monovision contact lens wear;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05765227). 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.