Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye, Sjogren's Syndrome, Dry Eye
Conditions
Keywords
contact lens care
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 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.
Interventions
DEVICETangible Boost
Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
OTHERPlacebo
Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
Sponsors
Tangible Science
Boston Sight
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Test and placebo treatment kits will be randomized by the sponsor prior to sending to clinical site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 3 months | LogMAR visual acuity |
| Contact Lens Comfort | 3 months | OSDI plus additional specific questions |
| Ocular Surface Staining | 3 months | 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. |
| Tear Break up Time | 3 months | Seconds required for tear film to begin to break up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Fit Characteristics | 6 months | Patients with substantial changes in apical clearance, limbal clearance, scleral landing evaluation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren Carrasquillo, OD, PhD
Boston Sight
Participant flow
Recruitment details
The subject pool consisted of patients of the Boston Sight clinic. Interested patients were directed to the principal investigator or the study coordinator, who went over the study and asked the screening questions. Recruitment occurred from February 2020 to December 2022.
Pre-assignment details
Subjects were assigned to a study group upon enrollment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Contact Lens Comfort | 29.6 OSDI score STANDARD_DEVIATION 18.6 |
| Ocular Surface Staining | 3.5 units STANDARD_DEVIATION 3 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
| Tear break up time | 8.1 seconds STANDARD_DEVIATION 4.8 |
| Visual Acuity | 0.24 logMAR units STANDARD_DEVIATION 0.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 1 / 11 | 1 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
None listed