NCT04313725|TerminatedResultsFDA Device
Study Stopped
Slow enrollment and difficulty getting patients to complete the study visits (significantly impacted by COVID-19 pandemic)
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Slow enrollment and difficulty getting patients to complete the study visits (significantly impacted by COVID-19 pandemic)
An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
Sponsor study identifier
interventional
28
1 country
1
Study Start
February 24, 2020
Actual (reported)Primary Completion
June 21, 2023
Actual (reported)Study Completion
June 21, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 21, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2020
Actual (reported)March 16, 2020
Actual (reported)March 18, 2020
Actual (reported)June 21, 2023
Actual (reported)June 21, 2023
Actual (reported)October 28, 2026
Actual (reported)Visual Acuity
LogMAR visual acuity
3 months
Visual Acuity
LogMAR visual acuity
6 months
Contact Lens Comfort
OSDI plus additional specific questions
3 months
Contact Lens Comfort
OSDI plus additional specific questions
Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.
Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study.
Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
Boston Sight
Needham, Massachusetts, 02494, United States
Karen Carrasquillo, OD, PhD
Boston Sight
28 participants (actual enrollment reported by the registry).
First Submitted
March 16, 2020
First Posted
March 18, 2020
Study Start
February 24, 2020
Actual (reported)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
Contact Lens Fit Characteristics
6 months
Contact the study team to confirm eligibility.
Primary Completion
June 21, 2023
Actual (reported)Study Completion
June 21, 2023
Actual (reported)Last Updated
October 28, 2026
Results First Posted
October 28, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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