Clinical trial NCT04313725: Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
Official title: An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stevens-Johnson Syndrome
Graft Versus Host Disease in Eye
Sjogren's Syndrome
Dry Eye
Keywords: contact lens care
Lead sponsor: Tangible Science
Sponsor class: INDUSTRY
Collaborators: name: Boston Sight
First posted: 2020-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 months
measure: Visual Acuity
timeFrame: 6 months
measure: Contact Lens Comfort
timeFrame: 3 months
measure: Contact Lens Comfort
timeFrame: 6 months
measure: Ocular Surface Staining
timeFrame: 3 months
measure: Ocular Surface Staining
timeFrame: 6 months
measure: Tear break up time
timeFrame: 3 months
measure: Tear break up time
timeFrame: 6 months
Secondary outcomes:
measure: Contact lens fit characteristics
timeFrame: 6 months
Other outcomes:
Locations:
city: Needham
country: United States
facility: Boston Sight
state: Massachusetts
Study officials:
affiliation: Boston Sight
name: Karen Carrasquillo, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: