title: Novel plasminogen and hyaluronate sodium eye drop formulation for a patient with ligneous conjunctivitis.
abstract: OBJECTIVE
  The development, analysis, and first clinical use of a novel eye drop formulation of plasminogen and hyaluronate sodium for the treatment of a patient with ligneous conjunctivitis (LC) are described.
  
  
  CONCLUSIONS
  LC is a chronic inflammatory disorder of the eye that can in rare cases lead to corneal involvement and subsequent blindness. Topically administered plasminogen is an effective treatment for LC; however, the lack of a specific and validated formulation of plasminogen for topical treatment can constitute a gap in the quality of care. A novel formulation of plasminogen and hyaluronate sodium for the treatment of LC was developed by combining commercially available products. Through a series of tests, including microbiological, viscosity, and pH analyses, the novel eye drop formulation was demonstrated to have constant activity (3.3 IU/mL or greater), to be microbiologically stable (i.e., sterile), and to be safe enough for daily administration. The first clinical application of the novel eye drop formulation was in the case of a nine-year-old girl with LC affecting both eyes. Initially, the girl's parents administered two drops every three hours to the left eye each day while the girl was awake. On examination after 30 days of daily use of the eye drop formulation, the patient was found to have a clear cornea and no membrane development on the conjunctiva; the formulation was subsequently administered in both eyes, with positive results.
  
  
  CONCLUSIONS
  A new formulation of plasminogen plus hyaluronate sodium was developed, tested, and used successfully in a girl with LC.
authors.affiliation: Healthcare Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Franca Manganelli
authors.initials: FM
authors.lastname: Conforti
authors.affiliation: Laboratory Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Giovina
authors.initials: G
authors.lastname: Di Felice
authors.affiliation: Laboratory Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Bernaschi
authors.affiliation: Pediatrics Medicine Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Bartuli
authors.affiliation: Healthcare Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bianco
authors.affiliation: University-Hospital Pediatric Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Simonetti
authors.affiliation: Department of Surgery, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Buzzonetti
authors.affiliation: Department of Surgery, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Valente
authors.affiliation: Healthcare Department, Research Institute, Bambino Gesú Children's Hospital, Rome, Italy. tiziana.corsetti@opbg.net.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Corsetti
mesh_terms: D060433:Administration, Ophthalmic; D002626:Chemistry, Pharmaceutical; D002648:Child; D003231:Conjunctivitis / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D009883:Ophthalmic Solutions; D010958:Plasminogen / Q000008:administration & dosage* / Q000172:deficiency*; D012873:Skin Diseases, Genetic / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D009883:Ophthalmic Solutions; D010958:Plasminogen; D006820:Hyaluronic Acid