Evaluation of Tangible Boost Replenishing System

Tangible Science

Status

Completed

Conditions

Contact Lens Solution

Treatments

Other: Placebo saline

Device: Tangible Boost

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03073148

113133

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Habitual contact lens wear with a group 3 FDA approved rigid lens material, with 20-50% of subjects wearing corneal lenses
Willing and able to sign the informed consent form
18 years or older

Exclusion criteria

Eye injury or surgery within the 3 months immediately prior to enrollment for this trial
Pre-existing ocular irritation that would preclude contact lens fitting
Current enrollment in an ophthalmic clinical trial
Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator
Pregnant women and nursing mothers
Visual acuity less than 20/20 when best corrected with contact lenses