Dry Eyes Clinical Trial
Official title:
Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol
The purpose of this research is to:
1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have
been diagnosed with graft-versus-host disease (GVHD), which is a complication that may
occur after bone marrow transplant where the newly transplanted material attacks the
patient's body and may cause eye dryness.
2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the
process in GVHD before the patient undergoes bone marrow transplant.
3. Compare how well Lotemax works in decreasing the process in GVHD with an
immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of
this condition.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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