NCT04158466

A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens

A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Detailed description

Approximately 247 participants (494 eyes) will be enrolled in at approximately 20 investigative sites in the United States (US). A minimum of 20% of the randomized participants will be of Japanese descent (for example, both maternal and paternal grandparents born in Japan).

Conditions

• Contact Lens Wear

Interventions

Type	Name	Description
DEVICE	Kalifilcon A Daily Disposable Contact Lenses	Contact lens
DEVICE	Biotrue ONEday Daily Disposable Contact Lenses	Contact lens

Timeline

• Start date: 2019-05-31
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2019-11-08
• Last updated: 2020-11-19
• Results posted: 2020-11-19

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study