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Safety and Effectiveness of the Qualis Contact Lens

Refractive Errors Clinical Trial

Official title:
Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens Over 3 Months of Daily Wear

Clinical Trial Summary

Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.

Clinical Trial Description

Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft Contact Lens for Daily Wear with the currently marketed Acuvue Vita (senofilcon C) Monthly Contact Lens (FDA cleared under K160212). Eligible subjects will be examined for baseline evaluation and lens fitting. Up to fifty (50) subjects will wear the test contact lenses and up to twenty-five (25) subjects will wear the control contact lenses. The subjects will undergo standard ophthalmic evaluation for contact lens wear and will be followed for a period of at least ninety (91) days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04295499
Study type Interventional
Source Unicon Optical Co. Ltd.
Contact
Status Completed
Phase N/A
Start date July 1, 2020
Completion date January 28, 2021
View Details
See also
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