Stevens-Johnson SyndromeNCT04313725
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
A study testing Tangible Boost in people with Stevens-Johnson Syndrome and Graft Versus Host Disease in Eye, run by Tangible Science at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye, Sjogren's Syndrome
- What is being tested?
- Tangible Boost
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
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.
- Being tested
- Tangible Boost, Placebo
- Keywords
- contact lens care
- Medical subject headings
- Stevens-Johnson Syndrome, Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tangible BoostDevice
Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
PlaceboOther
Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Boost | Experimental | Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study. Receives: Device: Tangible Boost |
| Placebo | Placebo comparator | Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
LogMAR visual acuity
Measured: 3 months
Visual Acuity
LogMAR visual acuity
Measured: 6 months
Contact Lens Comfort
OSDI plus additional specific questions
Measured: 3 months
Contact Lens Comfort
OSDI plus additional specific questions
Measured: 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.
Measured: 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.
Measured: 6 months
Tear Break up Time
Seconds required for tear film to begin to break up
Measured: 3 months
Tear Break up Time
Seconds required for tear film to begin to break up
Measured: 6 months
Secondary outcomes (1)
Contact Lens Fit Characteristics
Patients with substantial changes in apical clearance, limbal clearance, scleral landing evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start24 Feb 2020
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Why it stopped: Slow enrollment and difficulty getting patients to complete the study visits (significantly impacted by COVID-19 pandemic)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stevens-Johnson SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tangible Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Sight
- Responsible party
- Sponsor
- Investigators
- Karen Carrasquillo, OD, PhD, Principal investigator, Boston Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313725
- Sponsor's protocol ID
- DOC-55
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2020
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT04313725
- Acronym / sponsor ID
- DOC-55
- Keywords
- contact lens care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and difficulty getting patients to complete the study visits (significantly impacted by COVID-19 pandemic)
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tangible ScienceIndustry (pharma, biotech, devices)
- Collaborators
- Boston Sight
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boost | Experimental | Device: Tangible BoostSubjects will use the Tangible Boost treatment on their lenses monthly throughout the study. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will use a Placebo treatment (saline) on their lenses monthly throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tangible BoostPatients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses. | Device | Boost |
| PlaceboPatients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses. | Other | Placebo |
Primary outcome
Visual Acuity
Time frame: 3 months
LogMAR visual acuity
Visual Acuity
Time frame: 6 months
LogMAR visual acuity
Contact Lens Comfort
Time frame: 3 months
OSDI plus additional specific questions
Contact Lens Comfort
Time frame: 6 months
OSDI plus additional specific questions
Ocular Surface Staining
Time frame: 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.
Ocular Surface Staining
Time frame: 6 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
Time frame: 3 months
Seconds required for tear film to begin to break up
Tear Break up Time
Time frame: 6 months
Seconds required for tear film to begin to break up
1 secondary outcome
Contact Lens Fit Characteristics
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stevens-Johnson Syndrome
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
Not yet recruitingPhase 4
HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness
Gout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis
Not yet recruitingPhase 1/2
New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.
Toxic Epidermal Necrolysis, Immunotherapy
RecruitingPhase 1/2
LYell SYndrome MEsenchymal Stromal Cells Treatment
Epidermal Necrolysis, Lyell Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Carrasquillo, OD, PhD principal investigator
Boston Sight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tangible Boost in people with Stevens-Johnson Syndrome and Graft Versus Host Disease in Eye, run by Tangible Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.