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

Tangible Science

Status: Terminated

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

Treatments: Device: Tangible Boost; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04313725

DOC-55

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

28 participants in 2 patient groups, including a placebo group

Boost

Experimental group

Description:

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

Treatment:

Device: Tangible Boost

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo