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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04313725
• Other study ID #: DOC-55
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2021
• Source: Tangible Science
• Contact: Kelly Mabry, Ph.D.
• Phone: +1 (650) 241-1045
• Email: kelly[@]tangiblescience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Graft Versus Host Disease in Eye
• Graft vs Host Disease
• Sjogren's Syndrome
• Stevens-Johnson Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Sight	Needham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tangible Science	Boston Sight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Snellan visual acuity	3 months
Primary	Visual Acuity	Snellan visual acuity	6 months
Primary	Contact Lens Comfort	OSDI plus additional specific questions	3 months
Primary	Contact Lens Comfort	OSDI plus additional specific questions	6 months
Primary	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
Primary	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
Primary	Tear break up time	Seconds required for tear film to begin to break up	3 months
Primary	Tear break up time	Seconds required for tear film to begin to break up	6 months
Secondary	Contact lens fit characteristics	Changes in apical clearance, limbal clearance, scleral landing evaluation	6 months