Graft Vs Host Disease Clinical Trial
Official title:
Evaluation of Dextenza in Patients With Ocular Graft Vs Host Disease (GVHD) and Effect on Ocular Surface Disease Outcomes.
Verified date | December 2021 |
Source | Massachusetts Eye and Ear Infirmary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety and efficacy of Dextenza intracanalicular insert in patients with ocular graft-versus-host disease (GVHD).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 13, 2021 |
Est. primary completion date | December 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients diagnosed as chronic ocular GVHD - Age >= 18 years - Corneal Fluorescein Staining = 4 - Ocular Surface Disease Index =22. Exclusion Criteria: - History of immune diseases other than GVHD, herpetic keratitis or ocular malignancy - Treatment regimen changes with topical cyclosporine, autologous serum, anakinra, or oral tetracycline compounds within 30 days prior to enrollment; - Treatment regimen changes with systemic immunosuppressants or topical anti-glaucoma medications within 15 days prior to enrollment - Current use of topical steroids more than twice a day - Current or history of steroid induced ocular hypertension or glaucoma - Family history of steroid induced ocular hypertension or glaucoma - History of any intra-ocular surgery in the past 3 months or contact lens use within 2 weeks prior to enrollment - History of collagen (prolong) intra-canalicular plug within 6 months - Inability to cooperate for a comprehensive ocular examination - History of lid deformity or neuroparalytic lid disease - Active ocular infection including herpetic disease |
Country | Name | City | State |
---|---|---|---|
United States | Mass Eye and Ear | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts Eye and Ear Infirmary | Ocular Therapeutix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corneal Fluorescein Staining Score | Difference in the reduction of corneal fluorescein staining (CFS) compared to the contralateral eye. The cornea is divided into five zones (central, superior, temporal, nasal, and inferior) and for each zone, the severity of corneal fluorescein staining is graded on a scale from 0 to 3. Therefore, the maximum score is 15 for each eye. A higher score correlates to higher severity. | 4 weeks | |
Primary | Lissamine green staining score | The difference in the reduction of lissamine green staining compared to the contralateral eye. Six regions are graded for each eye (3 nasal conjunctival regions and 3 temporal conjunctival regions) from 0-3. Thus, a maximum score of 18 is possible for each eye. A higher score correlates to higher severity. | 4 Weeks | |
Primary | Symptomatic Relief | The difference in symptomatic relief from baseline to 4 weeks, as compared to the contralateral eye using The Symptom Assessment Questionnaire iN Dry Eye Questionnaire (SANDE). SANDE is a visual analog scale questionnaire that quantifies the severity and frequency of dry eye symptoms. Subjects mark on a 100 mm horizontal linear visual analog scale, with a pen or pencil, their frequency, and severity. By measuring, in mm, where each scale was marked, a score can be obtained, from 0 to 100, where a higher score correlates to more frequent and more severe symptoms. | 4 Weeks | |
Secondary | The Symptom Assessment Questionnaire iN Dry Eye Questionnaire | The difference in the improvement of the symptom assessment in dry eye (SANDE) questionnaire score compared to the contralateral eye at 4 and 8 week. SANDE is a visual analog scale questionnaire that quantifies the severity and frequency of dry eye symptoms. Subjects mark on a 100 mm horizontal linear visual analog scale, with a pen or pencil, their frequency, and severity. By measuring, in mm, where each scale was marked, a score can be obtained, from 0 to 100, where a higher score correlates to more frequent and more severe symptoms. | 8 Weeks | |
Secondary | Schirmer's Test | The differences in the improvement of Schirmer's test compared to the contralateral eye. Topical anesthetic is placed in the eye, and Schirmers test strips are placed in the temporal fornix of each eye. Patients are then instructed to close their eyes and after 5 minutes, the Schirmer strips are removed. The amount of wetting of each strip is read off of the strip and recorded. Values range from 0 to 35. Lower scores indicate lower tear production and greater ocular surface disease. | 8 Weeks | |
Secondary | Tear Break Up Time | The differences in the improvement of Tear Break Up Time (TBUT) compared to the contralateral eye. After instillation of fluorescein, the patient is asked to close their eyes, then open the eye and keep it open. The amount of time between opening the eye and visible disruption of the tear film is recorded in seconds. The same procedure is repeated for the fellow eye. Time can range from 0 seconds (instantaneous break up) to >10 seconds. Lower times indicate greater ocular surface disease. | 8 Weeks |
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