NCT03537248

A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution

Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Asepticys LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).

Detailed description

Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen.

Conditions

• Contact Lens Wear

Interventions

Type	Name	Description
DEVICE	ASP-57	an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
DEVICE	ReNu® Multiplus	a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses

Timeline

• Start date: 2018-04-23
• Primary completion: 2018-10-30
• Completion: 2018-10-30
• First posted: 2018-05-25
• Last updated: 2019-02-11

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study