Characteristics of ongoing studies [ordered by study ID].

NCT01721694
Trial name or title	Antibiotic Steroid Combination Compared With Individual Administration in the Treatment of Ocular Inflammation and Infection
Methods	Study design: interventional, randomized, parallel-group design, double-blinded (participant, investigator) trial
	Expected number to be randomized:
	Total: 60 participants
	Per group: 30 participants
	Unit of analysis: 1 eye per individual
	Reported power calculation: not reported
Participants	Country: Brazil
	Age: eligibility is 18 years and older
	Gender (male:female): the study has not yet recruited participants, but plan to recruit both genders
	Inclusion criteria: central or paracentral corneal ulcers severe enough to warrant admission to the hospital
	Exclusion criteria: identification of fungal isolates, perforated ulcers or descemetoceles, underlying viral corneal conditions, atopic ulcers; no light perception on admission; less than 13 years of age
Interventions	Intervention 1: fixed combination of azithromycin 1.5%/loteprednol 0.5% eye drops + placebo eye drops
	Intervention 2: azithromycin 1.5% + loteprednol 0.5% eye drops (separately)
Outcomes	Primary outcome measures: “clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study” on day 8
	Secondary outcome measures: eradication of pathogens defined as “success obtained with microbiological irradication of pathogens present at baseline” on day 8
	Other outcome measures: “decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting” on day 4 and day 8
Starting date	December 2012
Contact information	Cristina Muccioli, MD: 5511-99748809; crissmucci@gmail.com
	Luci Silva, MBA: 5511-71571967; luci.pesquisa@gmail.com
	Locations: Brazil
	Department of Ophthalmology of Hospital São Paulo
	São Paulo, Brazil, 04023-062
	Principal Investigator: Rubens Belfort, MD
	Sub-Investigator: Cristina Muccioli, MD
Notes	Estimated study completion date: May 2013
	The study had not yet recruited participants as of 5 November 2012
	The study is sponsored by Adapt Produtos Oftalmológicos Ltda

IOP: intraocular pressure