June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Prospective, Randomized, Double-Masked Clinical Trial Comparing Safety and Efficacy of Topical Tacrolimus vs. Methylprednisolone for Ocular Graft-Versus-Host Disease
Author Affiliations & Notes
  • Ujwala Sachin Saboo
    Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA
  • Tulio Abud
    Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA
  • Francisco Amparo
    Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA
  • Joseph B Ciolino
    Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA
  • Pedram Hamrah
    Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA
  • Reza Dana
    Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA
  • Footnotes
    Commercial Relationships Ujwala Saboo, None; Tulio Abud, None; Francisco Amparo, None; Joseph Ciolino, None; Pedram Hamrah, None; Reza Dana, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 303. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      Ujwala Sachin Saboo, Tulio Abud, Francisco Amparo, Joseph B Ciolino, Pedram Hamrah, Reza Dana; Prospective, Randomized, Double-Masked Clinical Trial Comparing Safety and Efficacy of Topical Tacrolimus vs. Methylprednisolone for Ocular Graft-Versus-Host Disease. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):303.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose: To evaluate the safety and efficacy of topical tacrolimus 0.05% vs. topical methylprednisolone 0.5% in patients with ocular graft-versus-host disease.

Methods: Prospective, randomized, double masked clinical trial evaluating 40 patients treated with topical tacrolimus 0.05% (N=24) or methylprednisolone 0.5% (N=16) twice a day for 10 weeks. The following clinical signs were evaluated: corneal fluorescein staining (CFS), tear break-up time (TBUT) and Schirmer test. Symptoms were evaluated using the Ocular Surface Disease Index© (OSDI). Tolerability was assessed based on subjects’ reports of discomfort after drop instillation; adverse events and intraocular pressure (IOP) were also assessed.

Results: No major adverse events were reported during the study. There was no significant difference in the tolerability scores between the two groups (P=0.053); however, burning sensation upon drug instillation was more frequent in the tacrolimus vs. methylprednisolone (P<0.001). Topical tacrolimus was more effective than methylprednisolone in reducing the CFS score (55% vs. 23%, respectively; P=0.015) and increasing the TBUT (P<0.001) after 10 weeks of treatment. There was a statistically significant reduction of OSDI with tacrolimus (P=0.024) but not with methylprednisolone (P=0.057). The Schirmer scores did not change in either group. Treatment with methylprednisolone modestly increased IOP when compared to baseline values (P=0.04).

Conclusions: Topical tacrolimus 0.05% is safe, effective and generally well tolerated for the treatment of ocular graft-versus-host disease, without the hypertensive side effect of topical corticosteroid therapy.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×