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

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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

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.
    



Study Type

Interventional


Primary Outcome

Visual Acuity

Secondary Outcome

 Contact lens fit characteristics

Condition

Stevens-Johnson Syndrome

Intervention

Tangible Boost

Study Arms / Comparison Groups

 Boost
Description:  Subjects will use the Tangible Boost treatment on their lenses monthly throughout the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

February 24, 2020

Completion Date

March 31, 2022

Primary Completion Date

March 31, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karen Carrasquillo, OD, PhD, +1 (650) 241-1045, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04313725

Organization ID

DOC-55


Responsible Party

Sponsor

Study Sponsor

Tangible Science

Collaborators

 Boston Sight

Study Sponsor

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


Verification Date

March 2021