NCT04295499

Safety and Effectiveness of the Qualis Contact Lens

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Unicon Optical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	soft (hydrophilic) contact lens	The intervention is a daily wear soft contact lens

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-01-28
• Completion: 2021-01-28
• First posted: 2020-03-04
• Last updated: 2023-10-19
• Results posted: 2023-06-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study