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Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease

Primary Purpose

Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye, Sjogren's Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tangible Boost
Placebo
Sponsored by
Tangible Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stevens-Johnson Syndrome focused on measuring contact lens care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston SightRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Boost

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Visual Acuity
Snellan visual acuity
Visual Acuity
Snellan visual acuity
Contact Lens Comfort
OSDI plus additional specific questions
Contact Lens Comfort
OSDI plus additional specific questions
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.
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.
Tear break up time
Seconds required for tear film to begin to break up
Tear break up time
Seconds required for tear film to begin to break up

Secondary Outcome Measures

Contact lens fit characteristics
Changes in apical clearance, limbal clearance, scleral landing evaluation

Full Information

First Posted
March 16, 2020
Last Updated
March 29, 2021
Sponsor
Tangible Science
Collaborators
Boston Sight
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1. Study Identification

Unique Protocol Identification Number
NCT04313725
Brief Title
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
Official Title
An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tangible Science
Collaborators
Boston Sight

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye, Sjogren's Syndrome, Dry Eye
Keywords
contact lens care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Test and placebo treatment kits will be randomized by the sponsor prior to sending to clinical site.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Boost
Arm Type
Experimental
Arm Description
Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study.
Intervention Type
Device
Intervention Name(s)
Tangible Boost
Intervention Description
Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Snellan visual acuity
Time Frame
3 months
Title
Visual Acuity
Description
Snellan visual acuity
Time Frame
6 months
Title
Contact Lens Comfort
Description
OSDI plus additional specific questions
Time Frame
3 months
Title
Contact Lens Comfort
Description
OSDI plus additional specific questions
Time Frame
6 months
Title
Ocular Surface Staining
Description
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
Title
Ocular Surface Staining
Description
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
Title
Tear break up time
Description
Seconds required for tear film to begin to break up
Time Frame
3 months
Title
Tear break up time
Description
Seconds required for tear film to begin to break up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Contact lens fit characteristics
Description
Changes in apical clearance, limbal clearance, scleral landing evaluation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Mabry, Ph.D.
Phone
+1 (650) 241-1045
Ext
108
Email
kelly@tangiblescience.com
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle Crowley
Phone
781-726-7506
Email
ecrowley@bostonsight.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Carrasquillo, OD, PhD
Organizational Affiliation
Boston Sight
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Sight
City
Needham
State/Province
Massachusetts
ZIP/Postal Code
02494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Crowley
Phone
781-726-7506
Email
ecrowley@bostonsight.org
First Name & Middle Initial & Last Name & Degree
Karen Carrasquillo, OD, PhD
Phone
781-726-7518
Email
kcarrasquillo@bostonsight.org
First Name & Middle Initial & Last Name & Degree
Karen Carrasquillo, OD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease

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