Phase 1
N=40
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
Ocular GVHD
Bottom Line
View on ClinicalTrials.gov: NCT01977781 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation — 3.50; 2.23; 0.16; 0.26 units on a scale — p=0.0019
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tacrolimus (Drug); Methylprednisolone Sodium Succinate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation |
3.50; 2.23; 0.16; 0.26; 1.25; 0.43 | 0.0019 sig |
| SECONDARY Ocular Surface Disease Index (OSDI) Questionnaire |
42; 28 | — |
| SECONDARY Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme) |
3.7; 6.6 | — |
| SECONDARY Schirmer Tear Test (mm) |
3.5; 3.5 | — |
| SECONDARY Tear Film Break-Up Time |
2.6; 1.0 | — |
| SECONDARY Visual Acuity |
0.13; 0.13 | — |
| SECONDARY Intraocular Pressure |
16.5; 17.1 | — |
Summary
The purpose of this study is to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of ocular graft versus host disease (GVHD).
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- Diagnosis of ocular GVHD.
- Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
- Ocular Surface Disease Index score >22.
- In good stable overall health.
Exclusion Criteria
- History of immune disease other than GVHD.
- Ocular or periocular malignancy.
- Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
- Any history of topical tacrolimus use.
- Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
- Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
- Current use of topical steroids more than twice a day.
- Change in frequency of serum tears, topical cyclosporine and/or topical kineret within the last month.
- Corneal epithelial defect >1mm2.
- Any history of herpetic keratitis.
- Participation in another simultaneous medical research study.
- Signs of current infection, including fever and current treatment with antibiotics.
- Intra-ocular surgery or ocular laser surgery within 3 months.
- Pregnancy (positive pregnancy test) or lactating
- Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
- Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Data sourced from ClinicalTrials.gov (NCT01977781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.