Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
NCT ID: NCT04313725
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
28 participants
INTERVENTIONAL
2020-02-24
2023-06-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Boost
Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.
Tangible Boost
Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
Placebo
Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study.
Placebo
Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
Interventions
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Tangible Boost
Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
Placebo
Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Sight
OTHER
Tangible Science
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Carrasquillo, OD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Sight
Locations
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Boston Sight
Needham, Massachusetts, United States
Countries
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Other Identifiers
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DOC-55
Identifier Type: -
Identifier Source: org_study_id
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