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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The purpose of this research is to:
Allogeneic bone marrow or peripheral stem cell transplantation result in Graft-versus-Host disease. Ocular symptoms may be the first presentation of GVHD and may be seen in the absence of systemic manifestations. GVHD is categorized into acute and chronic forms as defined by 100 days after the transplant. Acute GVHD is characterized by dermatitis, hepatitis, and enteritis. Chronic GVHD involves the skin, mouth, liver, gastrointestinal tract, lungs, and eyes. Ocular GVHD is a common cause of dry eye symptoms in patients who have undergone bone marrow transplant (BMT), and can be defined as ocular surface disease in the context of GVHD. Dry eyes develop in 76% of acute GVHD patients and between 62.5% and 81.8% of chronic GVHD patients. Current treatment for ocular GVHD includes topical cyclosporine 0.05% (Restasis, Allergan). Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been prospectively studied in ocular GVHD.
2. Hypothesis: We anticipate that topical loteprednol etabonate 0.5% will be safe and efficacious in treatment of ocular GVHD patients, and would add to the armamentarium of therapeutics for this disease. Further, by following the natural progression of the disease prior to a patient's Bone Marrow Transplant (BMT), we may elucidate a new standard of care for these patients - one that involves referral to an ophthalmologist before ocular GVHD symptoms arise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotemax | Experimental | Loteprednol Etabonate 0.5% |
|
| Restasis | Active Comparator | Cyclosporine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotemax | Drug | Ophthalmic corticosteroid. It decreases inflammation of the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression of Dry Eye Severity | Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions. | 1 year |
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Inclusion Criteria:
Scheduled for allogenic bone marrow transplant
Exclusion Criteria:
Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
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| Name | Affiliation | Role |
|---|---|---|
| Shahzad Mian, MD | University of Michigan | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotemax | Loteprednol Etabonate 0.5% |
| FG001 | Restasis | Cyclosporine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lotemax | Loteprednol Etabonate 0.5% |
| BG001 | Restasis | Cyclosporine |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression of Dry Eye Severity | Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions. | Posted | Number | patients with increased dry eye severity | 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lotemax | Loteprednol Etabonate 0.5% Lotemax |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe Dry eye | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shahzad Mian | University of Michigan | 734-647-8397 | smian@med.umich.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D003524 | Cyclosporins |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Restasis | Drug | Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye. |
|
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 9 |
| 38 |
| 15 |
| 38 |
| EG001 | Restasis | Cyclosporine Restasis | 17 | 37 | 12 | 37 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |