Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease

An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease

The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens.

Hydra-PEG is a coating for soft and rigid contact lens, primarily composed of polyethylene glycol-based hydrogel, which is covalently bound to the surface of a contact lens. The Hydra-PEG coating is intended to improve wettability and comfort with contact lenses and is currently FDA approved on a number of contact lenses. For patients with Stevens Johnson Syndrome (SJS) (SS), or Graft versus Host disease (GVHD), diminished efficacy of the Hydra-PEG coating can lead to significant decline in satisfaction with the lenses over time. This is a prospective study to evaluate the efficacy of Tangible Boost, a monthly conditioning solution, to replenish the Hydra-PEG coating on rigid gas permeable contact lenses for patients with SJS, GVHD, and SS. Outcomes from this patient population will be compared to patients with dry eye disease.

Study Overview

• Status: Terminated
• Conditions: Dry Eye; Stevens-Johnson Syndrome; Sjogren's Syndrome; Graft Versus Host Disease in Eye
• Intervention / Treatment: Device: Tangible Boost; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Needham, Massachusetts, United States, 02494
      • Boston Sight

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written Informed Consent has been obtained prior to any study-related procedures taking place
• Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
• Male or female
• 18 years of age and older prior to the initial visit
• Is a new or established wearer of PROSE lenses with optimized lens fit prior to enrollment in the study
• Has been diagnosed with Dry Eye Syndrome, SJS, SS, or GVHD
• In the opinion of the investigator, the subject has the ability to follow study instructions
• In the opinion of the investigator, the subject has the ability to complete all study procedures and visits

Exclusion Criteria:

• aphakic (i.e., missing their natural lens inside the eye)
• Is currently participating in any other type of eye-related clinical or research study
• Is pregnant or nursing as reported by the subject
• Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
• Has a known and self-reported allergy to the following substances: polyethylene glycol, polyvinyl alcohol, triethanolamine, polyquaternium-1, or edetate disodium, which are components of the Tangible Boost and Hydra-PEG systems or care regimen.
• Has had previous ocular surgery within the past 12 weeks
• Adults unable to consent (including adults unable to read and understand English)
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Employees of BostonSight

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Boost; Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.	Device: Tangible Boost; Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
Placebo Comparator: Placebo; Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study.	Other: Placebo; Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Snellan visual acuity	3 months
Visual Acuity	Snellan visual acuity	6 months
Contact Lens Comfort	OSDI plus additional specific questions	3 months
Contact Lens Comfort	OSDI plus additional specific questions	6 months
Ocular Surface Staining	Sodium fluorescein staining will be used to evaluate ocular surface damage indicated by cell damage or death. Corneal staining will be scored using the Oxford grading scale.	3 months
Ocular Surface Staining	Sodium fluorescein staining will be used to evaluate ocular surface damage indicated by cell damage or death. Corneal staining will be scored using the Oxford grading scale.	6 months
Tear break up time	Seconds required for tear film to begin to break up	3 months
Tear break up time	Seconds required for tear film to begin to break up	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact lens fit characteristics	Changes in apical clearance, limbal clearance, scleral landing evaluation	6 months

Collaborators and Investigators

• Sponsor: Tangible Science
• Collaborators: Boston Sight
• Investigators: Principal Investigator: Karen Carrasquillo, OD, PhD, Boston Sight

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: contact lens care
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Hypersensitivity; Chemically-Induced Disorders; Skin Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Lacrimal Apparatus Diseases; Drug-Related Side Effects and Adverse Reactions; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Dermatitis; Erythema; Drug Eruptions; Drug Hypersensitivity; Stomatitis; Erythema Multiforme; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Dry Eye Syndromes; Stevens-Johnson Syndrome; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: DOC-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No