At a glance
ClinicalIndex Comparison RecordN/ACompleted· 36 enrolled
Drug / intervention
Lehfilcon A contact lenses +2 moredevice
Likely dose
Lehfilcon A investigational silicone hydrogel contact lenses for daily wear with monthly replacementAI-extracted
Key inclusion· 3
- ✓Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
- ✓Possess spectacles providing corrected visual acuity of 20/40 or better in both eyes
- ✓Sign Informed Consent document
Key exclusion· 5
- ✕Any eye condition or disease that contraindicates contact lens wear
- ✕Eye surgery, irregular cornea, or eye injury (as specified in protocol)
- ✕Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment
- ✕Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
In Brief
A clinical study evaluating Lehfilcon A contact lenses, Comfilcon A contact lenses, and 1 other intervention for Refractive Errors. Completed, enrolled 36 participants across 3 sites.
Detailed Summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractive Errors
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2019
Primary CompletionDec 2019
TodayJul 2026
First PostedAug 13, 2019
Enrollment StartSep 19, 2019
Primary CompletionDec 3, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.9 years ago
Interventions
Lehfilcon A contact lensesdevice
Investigational silicone hydrogel contact lenses
Comfilcon A contact lensesdevice
Commercially available silicone hydrogel contact lenses
Multi-purpose disinfection solutiondevice
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses