NCT01912768

Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Detailed description

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Conditions

• Myopia
• Astigmatism
• Hyperopia
• Refractive Error

Interventions

Type	Name	Description
DEVICE	FID 120947A contact lens disinfecting solution	Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
DEVICE	renu fresh multi-purpose solution	Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
DEVICE	Soft contact lenses	Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-07-31
• Last updated: 2015-07-09
• Results posted: 2015-06-09