Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Completed · Phase 2
Conditions studied: Graft Versus Host Disease, Ophthalmologic Complications
In brief
This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.
Key facts
- Study ID
- NCT01616056
- Run by
- Fred Hutchinson Cancer Center
- People needed
- 20
- Starts
- 2012-06-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-07-17
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria
- Ocular symptoms of NIH eye score 2 or greater:
- Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops > 3 x per day or punctal plugs), WITHOUT vision impairment
- Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis
- No new systemic immunosuppressive medications within 1 month prior to enrollment
- Subject has the ability to understand and willingness to sign a written informed consent document
You may not qualify if…
- Absolute neutrophil count < 1000/ul
- Known hypersensitivity or allergy to contact lenses
- Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment
- Treatment with contact lenses within the previous 3 months for any indication
- Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol
Where it is running
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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