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

NCT04313725 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

DEVICE

Tangible Boost

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Boston Sight

    collaborator OTHER

  • Tangible Science

    lead INDUSTRY

Principal Investigators

  • Karen Carrasquillo, OD, PhD · Boston Sight

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2023-06-21
Completion
2023-06-21
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 NCT04313725 on ClinicalTrials.gov