N/A
Completed N=101
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Source: ClinicalTrials.gov NCT05338333 ↗Enrolled (actual)
101
Serious AEs
0.1%
Results posted
Sep 2023
Primary outcomePrimary: Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses — -0.10; -0.09 logMAR
Summary
The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses |
-0.10; -0.09 | — |
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
- Willing and able to attend all study visits as required by the protocol.
- Willing to stop wearing habitual contact lenses for the duration of the study.
- Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- Any eye infection, inflammation, 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 planning to have refractive surgery during the study.
- Current or history of pathologically dry eye.
- Currently pregnant or lactating.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05338333). 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.