N/A
N=36
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
Refractive Errors · Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT04403542 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Distance Visual Acuity (VA) With Study Lenses — -0.03; -0.04; -0.03; -0.03 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lehfilcon A contact lens (Device); Comfilcon A contact lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) With Study Lenses |
-0.03; -0.04; -0.03; -0.03; -0.03; -0.03 | — |
Summary
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an IRB/IEC approved Informed Consent form.
- Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
- Best corrected visual acuity of 20/25 or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- Any habitual wear of Biofinity contact lenses.
- Pregnant or breast-feeding.
- Other protocol specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04403542). 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.