N/A
Completed N=234
Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Source: ClinicalTrials.gov NCT04207749 ↗Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) — -0.06; -0.05 logMAR
Summary
The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) |
-0.06; -0.05 | — |
| SECONDARY Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) |
98.1; 97.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Understand and sign an IRB/IEC approved Informed Consent form.
- Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
- Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- Best spectacle corrected visual acuity 20/20 or better in each eye.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Monovision contact lens wear.
- Any habitual wear of Biofinity lenses.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04207749). 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.