N/A
N=66
Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT04476784 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Mean Distance Visual Acuity (logMAR) With Study Lenses — -0.11; -0.13; -0.12; -0.13 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lehfilcon A contact lenses (Device); Comfilcon A contact lenses (Device); CLEAR CARE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Distance Visual Acuity (logMAR) With Study Lenses |
-0.11; -0.13; -0.12; -0.13 | — |
Summary
The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.
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.