N/A
N=11
Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear
Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT03560141 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Visual Acuity (VA) With Study Lenses, Collected by Eye — -0.10; -0.11; -0.09; -0.12 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LID011121 contact lens (Device); Comfilcon A contact lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) With Study Lenses, Collected by Eye |
-0.10; -0.11; -0.09; -0.12; 0.02; -0.01 | — |
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 following 1 night of extended wear.
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an 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 per week in either a daily wear or extended wear modality.
- Best Corrected Visual Acuity (BCVA) 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.
- Current Biofinity® lens wearer.
- Pregnant or breast-feeding.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03560141). 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.