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Evaluation of Tangible Boost Replenishing System

NCT03073148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-11-17

Study results available
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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

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.

Sponsors & Collaborators

  • University of Houston

    collaborator OTHER

  • Tangible Science

    lead INDUSTRY

Principal Investigators

  • Maria K Walker, OD MS · University of Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2019-02-13
Completion
2019-02-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03073148 on ClinicalTrials.gov