Status:
TERMINATED
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
Lead Sponsor:
Tangible Science
Collaborating Sponsors:
Boston Sight
Conditions:
Stevens-Johnson Syndrome
Graft Versus Host Disease in Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04313725
Start Date
February 24 2020
End Date
June 21 2023
Last Update
September 16 2025
Active Locations (1)
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1
Boston Sight
Needham, Massachusetts, United States, 02494