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

NCT04313725 | Terminated FDA Device

• 1 other identifier: DOC-55
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stevens-Johnson Syndrome; Graft Versus Host Disease in Eye; Sjogren's Syndrome; Dry Eye

Keywords

contact lens care

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Contact lens fit characteristics

  6 months

Study Arms (2)

Boost

EXPERIMENTAL

Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.

Device: Tangible Boost

Placebo

PLACEBO COMPARATOR

Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study.

Other: Placebo

Interventions

Tangible Boost DEVICE

Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.

Boost

Placebo OTHER

Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tangible Science: lead
• Boston Sight: collaborator

Study Sites (1)

Boston Sight

Needham, Massachusetts, 02494, United States

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases

Study Officials

• Karen Carrasquillo, OD, PhD

  Boston Sight

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Test and placebo treatment kits will be randomized by the sponsor prior to sending to clinical site.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: February 24, 2020
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)