An interventional study of Lotemax and Restasis in Dry Eyes, sponsored by University of Michigan. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-24.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 75 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Scheduled for allogenic bone marrow transplant
Exclusion Criteria:
Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
Loteprednol Etabonate 0.5%
Drug: Lotemax
Cyclosporine
Drug: Restasis
Ophthalmic corticosteroid. It decreases inflammation of the eye
Also known as: Loteprednol
Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.
Also known as: cyclosporine
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.
Time frame: 1 year
| Milestone | Lotemax | Restasis |
|---|---|---|
| Started | 38 | 37 |
| Completed | 23 | 20 |
| Not completed | 15 | 17 |
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.
| patients with increased dry eye severity | Lotemax | Restasis |
|---|---|---|
| Progression of Dry Eye Severity | 15 | 12 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lotemax | — | 9/38 (23.7%) | 15/38 (39.5%) |
| Restasis | — | 17/37 (45.9%) | 12/37 (32.4%) |
| Event | Lotemax | Restasis |
|---|---|---|
| deathBlood and lymphatic system disorders | 9/38 | 17/37 |
| Event | Lotemax | Restasis |
|---|---|---|
| severe Dry eyeEye disorders | 15/38 | 12/37 |
| Age, Categorical(Participants) | Lotemax | Restasis | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 32 | 63 |
| >=65 years | 7 | 5 | 12 |
| Age, Continuous(years) | Lotemax | Restasis | Total |
|---|---|---|---|
| Mean | 54.06 ± 13.68 | 51.21 ± 14.44 | 52.64 ± 14.06 |
| Sex: Female, Male(Participants) | Lotemax | Restasis | Total |
|---|---|---|---|
| Female | 18 | 19 | 37 |
| Male | 20 | 18 | 38 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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University of Michigan