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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: Tangible Boost
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens care