At a glance
ClinicalIndex Comparison Record- ✓Successful history of silicone hydrogel or other soft contact lens wear (not daily disposable) in both eyes during the past 3 months, with at least 5 consecutive days of daily wear in both eyes at Visit 1
- ✓Best spectacle corrected distance visual acuity ≥0.8 (decimal) in each eye
- ✕Need to wear contact lenses on extended wear basis (overnight) during the study
- ✕Monocular vision or fit with only 1 lens
- ✕Use of daily cleaner and/or enzyme cleaner within 7 days prior to Visit 1
- ✕History of intolerance or hypersensitivity to any component of investigational products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Evaluation of the Safety and Efficacy of FID 120947A
In Brief
A clinical study evaluating FID 120947A contact lens disinfecting solution, Soft contact lenses (SCL), and 1 other intervention for Refractive Error. Completed, enrolled 91 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
Study Details
Timeline
Interventions
Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.
Commercially available solution for rinsing soft contact lenses