title: Human albumin eye drops as a therapeutic option for the management of keratoconjunctivitis sicca secondary to chronic graft-versus-host disease after stem-cell allografting.
abstract: BACKGROUND
  Keratoconjunctivitis sicca from chronic graft-versus-host disease (cgvhd) after allogeneic stem cell transplantation is common, leading to severe corneal damage and blindness if not treated. We retrospectively examined the efficacy and safety of pooled human albumin eye drops (haeds) for symptom relief in 40 stem-cell transplantation patients after other alternatives had failed.
  
  
  METHODS
  The Common Terminology Criteria for Adverse Events (version 4.0) and the cgvhd grading scale were used to compare response in the patients during January 2000 and July 2013. In addition, on days 1 and 30, the haeds were subjected to quality assurance testing for sterility, oncotic pressure, albumin measurement, viscosity, pH, and purity by protein electrophoresis.
  
  
  RESULTS
  Use of haeds resulted in symptom relief for 37 patients (92.5%); 3 patients (7.5%) failed to improve with use of haeds (p ≤ 0.0001). Of the 37 patients having symptom relief, 7 (19%) improved from grade 3 to no dry eye symptoms. Proportionately, post-treatment symptom improvement by two grade levels, from 3 to 1 (70%), was significantly higher than improvement by one grade level, from 3 to 2 (11%) or from 2 to 1 (19%, p ≤ 0.0001). Time to symptom relief ranged from 2 weeks to 28 weeks. Of the 40 patients, 38 (95%) had no adverse reactions. Days 1 and 30 quality assurance testing results were equivalent.
  
  
  CONCLUSIONS
  Complications of keratoconjunctivitis sicca were well managed and well tolerated with haeds when other remedies failed. Quality assurance testing confirmed that haeds were safe and stable in extreme conditions.
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON; ; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON; ; College of Pharmacy and Health Sciences, Drake University, IA, U.S.A.;
authors.forename: J T
authors.initials: JT
authors.lastname: Seki
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: N
authors.initials: N
authors.lastname: Sakurai
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON; ; College of Pharmacy and Health Sciences, Drake University, IA, U.S.A.;
authors.forename: S
authors.initials: S
authors.lastname: Moldenhauer
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: J
authors.initials: J
authors.lastname: Dam
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: E G
authors.initials: EG
authors.lastname: Atenafu
authors.affiliation: Toronto General Hospital, Toronto, ON;
authors.forename: P M
authors.initials: PM
authors.lastname: Yip
authors.affiliation: Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON; ; Mount Sinai Hospital, Toronto, ON;
authors.forename: T
authors.initials: T
authors.lastname: Mazzulli
authors.affiliation: The Hospital for Sick Children, Toronto, ON.
authors.forename: T
authors.initials: T
authors.lastname: Henderson
authors.affiliation: Toronto General Hospital, Toronto, ON;
authors.forename: J
authors.initials: J
authors.lastname: Pendergrast
authors.affiliation: Toronto General Hospital, Toronto, ON;
authors.forename: C
authors.initials: C
authors.lastname: Cserti
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: J P
authors.initials: JP
authors.lastname: Velazquez
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: R
authors.initials: R
authors.lastname: Simpson
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: G
authors.initials: G
authors.lastname: Felluga
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: H A
authors.initials: HA
authors.lastname: Messner
authors.affiliation: Princess Margaret Cancer Centre, Toronto, ON;
authors.forename: J H
authors.initials: JH
authors.lastname: Lipton
keywords: Post-transplant dry eye management