NCT03278223

One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: OTE North America · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.

Detailed description

This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.

Conditions

• Myopia
• Hyperopia

Interventions

Type	Name	Description
DEVICE	Test solution	A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
DEVICE	Control solution	A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.

Timeline

• Start date: 2017-08-14
• Primary completion: 2017-11-17
• Completion: 2017-12-20
• First posted: 2017-09-11
• Last updated: 2021-03-26
• Results posted: 2021-03-26

Locations

11 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study