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

• Sponsor: Tangible Science (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04313725
• Collaborator: Boston Sight (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.2
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stevens-Johnson Syndrome; Graft Versus Host Disease in Eye; Sjogren's Syndrome; Dry Eye	Device: Tangible Boost; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Test and placebo treatment kits will be randomized by the sponsor prior to sending to clinical site.
• Primary Purpose: Treatment
• Official Title: An Evaluation of Tangible Boost Replenishing System for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Versus Host Disease
• Actual Study Start Date: Feb 24, 2020
• Anticipated Primary Completion Date: Mar 31, 2022
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boost Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.	Device: Tangible Boost; Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
Placebo Comparator: Placebo Subjects will use a Placebo treatment (saline) on their lenses monthly throughout the study.	Other: Placebo; Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [3 months]

   Snellan visual acuity

2. Visual Acuity [6 months]

   Snellan visual acuity

3. Contact Lens Comfort [3 months]

   OSDI plus additional specific questions

4. Contact Lens Comfort [6 months]

   OSDI plus additional specific questions

5. 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.

6. Ocular Surface Staining [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.

7. Tear break up time [3 months]

   Seconds required for tear film to begin to break up

8. Tear break up time [6 months]

   Seconds required for tear film to begin to break up

Secondary Outcome Measures

1. Contact lens fit characteristics [6 months]

   Changes in apical clearance, limbal clearance, scleral landing evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Sight	Needham	Massachusetts	United States	02494

Sponsors and Collaborators

• Tangible Science
• Boston Sight

Investigators

• Principal Investigator: Karen Carrasquillo, OD, PhD, Boston Sight

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tangible Science
• ClinicalTrials.gov Identifier: NCT04313725
• Other Study ID Numbers: DOC-55
• First Posted: Mar 18, 2020
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Tangible Science: contact lens care
• Additional relevant MeSH terms: Sjogren's Syndrome; Stevens-Johnson Syndrome; Graft vs Host Disease; Syndrome

Study Results

No Results Posted as of Apr 1, 2021