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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
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, United States
Visual Acuity
Snellan visual acuity
Time frame: 3 months
Visual Acuity
Snellan visual acuity
Time frame: 6 months
Contact Lens Comfort
OSDI plus additional specific questions
Time frame: 3 months
Contact Lens Comfort
OSDI plus additional specific questions
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Tear break up time
Seconds required for tear film to begin to break up
Time frame: 3 months
Tear break up time
Seconds required for tear film to begin to break up
Time frame: 6 months
Contact lens fit characteristics
Changes in apical clearance, limbal clearance, scleral landing evaluation
Time frame: 6 months
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