N/A
Completed N=66
Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Source: ClinicalTrials.gov NCT04476784 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Mean Distance Visual Acuity (logMAR) With Study Lenses — -0.11; -0.13; -0.12; -0.13 logMAR
Summary
The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Distance Visual Acuity (logMAR) With Study Lenses |
-0.11; -0.13; -0.12; -0.13 | — |
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an approved Informed Consent form;
- Willing and able to attend all scheduled study visits as required by the protocol;
- Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Current or prior Biofinity contact lens wearer in the past 3 months;
- Monovision contact lens wearer;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04476784). 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.