Dry Eyes
Conditions
Keywords
Graft versus Host Disease (GVHD), dry eyes, Bone marrow transplant (BMT), Restasis, Lotemax
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Bausch & Lomb Incorporated
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Scheduled for allogenic bone marrow transplant
Exclusion criteria
Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of Dry Eye Severity | 1 year | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lotemax Loteprednol Etabonate 0.5% | 38 |
| Restasis Cyclosporine | 37 |
| Total | 75 |
Baseline characteristics
| Characteristic | Lotemax | Restasis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 32 Participants | 63 Participants |
| Age, Continuous | 54.06 years STANDARD_DEVIATION 13.68 | 51.21 years STANDARD_DEVIATION 14.44 | 52.64 years STANDARD_DEVIATION 14.06 |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 20 Participants | 18 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 38 | 12 / 37 |
| serious Total, serious adverse events | 9 / 38 | 17 / 37 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotemax | Progression of Dry Eye Severity | 15 patients with increased dry eye severity |
| Restasis | Progression of Dry Eye Severity | 12 patients with increased dry eye severity |