Trials / Terminated
TerminatedNCT04313725
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Tangible Science · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-02-24
- Primary completion
- 2023-06-21
- Completion
- 2023-06-21
- First posted
- 2020-03-18
- Last updated
- 2025-09-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04313725. Inclusion in this directory is not an endorsement.