NCT03897751

A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula ("COMPLETE Multi-Purpose Solution") when used by participants who are habitual contact lens wearers.

Detailed description

Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material: * Etaficon A, Acuvue2, Vistakon * Balafilcon A, PureVision2, Bausch + Lomb * Samfilcon A, Ultra, Bausch + Lomb * Lotrafilcon B, Optix Aqua, Alcon * Senofilcon C, Vita, Vistakon

Conditions

• Contact Lens Wear

Interventions

Type	Name	Description
DEVICE	ABT12 Multi-Purpose Solution	Contact lens cleaning and disinfecting solution
DEVICE	COMPLETE Multi-Purpose Solution	Contact lens cleaning and disinfecting solution
DEVICE	Sensitive Eyes® Rewetting Drops	For use as needed during the study.

Timeline

• Start date: 2019-03-08
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2019-04-01
• Last updated: 2023-03-03
• Results posted: 2022-11-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study