title: The steroids for corneal ulcers trial: study design and baseline characteristics.
abstract: OBJECTIVE
  To provide comprehensive trial methods and baseline data for the Steroids for Corneal Ulcers Trial and to present epidemiological characteristics such as risk factors, causative organisms, and ulcer severity.
  
  
  METHODS
  Baseline data from a 1:1 randomized, placebo-controlled, double-masked clinical trial comparing prednisolone phosphate, 1%, with placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and had been taking moxifloxacin for 48 hours. The primary outcome for the trial is best spectacle-corrected visual acuity at 3 months from enrollment. This report provides comprehensive baseline data, including best spectacle-corrected visual acuity, infiltrate size, microbiological results, and patient demographics, for patients enrolled in the trial.
  
  
  RESULTS
  Of 500 patients enrolled, 97% were in India. Two hundred twenty patients (44%) were agricultural workers. Median baseline visual acuity was 0.84 logMAR (Snellen, 20/125) (interquartile range, 0.36-1.7; Snellen, 20/50 to counting fingers). Baseline visual acuity was not significantly different between the United States and India. Ulcers in India had larger infiltrate/scar sizes (P = .04) and deeper infiltrates (P = .04) and were more likely to be localized centrally (P = .002) than ulcers enrolled in the United States. Gram-positive bacteria were the most common organisms isolated from the ulcers (n = 366, 72%).
  
  
  CONCLUSIONS
  The Steroids for Corneal Ulcers Trial will compare the use of a topical corticosteroid with placebo as adjunctive therapy for bacterial corneal ulcers. Patients enrolled in this trial had diverse ulcer severity and on average significantly reduced visual acuity at presentation.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00324168.
authors: Aravind Eye Care System, Madurai, India.
authors: Muthiah
authors: M
authors: Srinivasan
authors: Jeena
authors: J
authors: Mascarenhas
authors: Revathi
authors: R
authors: Rajaraman
authors: Meenakshi
authors: M
authors: Ravindran
authors: Prajna
authors: P
authors: Lalitha
authors: David V
authors: DV
authors: Glidden
authors: Kathryn J
authors: KJ
authors: Ray
authors: Kevin C
authors: KC
authors: Hong
authors: Catherine E
authors: CE
authors: Oldenburg
authors: Salena M
authors: SM
authors: Lee
authors: Michael E
authors: ME
authors: Zegans
authors: Stephen D
authors: SD
authors: McLeod
authors: Thomas M
authors: TM
authors: Lietman
authors: Nisha R
authors: NR
authors: Acharya
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001372:Aza Compounds / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D003315:Cornea / Q000382:microbiology; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011804:Quinolines / Q000627:therapeutic use*; D012107:Research Design; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D005938:Glucocorticoids; D011804:Quinolines; C009022:prednisolone phosphate; D011239:Prednisolone; D000077266:Moxifloxacin