NCT03073148

Evaluation of Tangible Boost Replenishing System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Tangible Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate Tangible Boost, a new contact lens care product which is designed to replenish the hydrogel layer on fluorosilicone acrylate lenses with Hydra-PEG. The Hydra-PEG coating is a poly(ethylene glycol)-based hydrogel that is covalently bound to the lens surface. This coating improves lens wettability, a common cause of patient discomfort. Tangible Boost is designed to maintain the wettability of Hydra-PEG lenses throughout the lens lifetime. Patients can use the Tangible Boost kit to reapply the Hydra-PEG coating each month at home.

Conditions

• Contact Lens Solution

Interventions

Type	Name	Description
DEVICE	Tangible Boost	Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses.
OTHER	Placebo saline	Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution.

Timeline

• Start date: 2017-02-24
• Primary completion: 2019-02-13
• Completion: 2019-02-13
• First posted: 2017-03-08
• Last updated: 2020-11-17
• Results posted: 2020-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study