Phase 4 N=500 Randomized Quadruple-blind Treatment

Steroids for Corneal Ulcers Trial

Corneal Ulcer · Eye Infections, Bacterial

Bottom Line

View on ClinicalTrials.gov: NCT00324168 ↗

Enrolled (actual)

500

Serious AEs

5.6%

Results posted

Jun 2013

Primary outcome: Primary: Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate — 0.48; 0.49 logMAR — p=0.82

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Antibiotics (Drug); Topical corticosteroid (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Thomas M. Lietman
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate	0.48; 0.49	0.82
SECONDARY Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment	3.07; 3.02	0.40
SECONDARY Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment	0.42; 0.41	0.873
SECONDARY Time to Resolution of Epithelial Defect	9.77; 9.43	0.44
SECONDARY Ocular Perforations	7; 8	>0.99
SECONDARY Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate	2.90; 2.87	0.39
SECONDARY Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate	0.50; 0.46	0.78
SECONDARY Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism	0.54; 0.36; 0.49; 0.52; 0.46; 0.26	0.30
SECONDARY Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group	0.06; -0.02; 0.36; 0.38; 1.00; 1.15	0.33
SECONDARY Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth	0.35; 0.26; 0.52; 0.47; 0.80; 0.86	0.31
SECONDARY Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size	0.18; 0.19; 0.39; 0.29; 0.53; 0.53	0.53

Summary

The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.

Eligibility Criteria

Inclusion Criteria

At Presentation:

Presence of a corneal ulcer at presentation

At Enrollment:

Presence of bacteria on blood or chocolate agar culture
Antibiotic given for > 48 hours
The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for f/u visits.
Appropriate consent

Exclusion Criteria

At Presentation:

Overlying epithelial defect < 0.75 mm at its greatest width at presentation
Corneal perforation or impending perforation
Evidence of fungus on KOH, Giemsa at time of presentation
Evidence of acanthamoeba by stain
Evidence of herpetic keratitis by history or exam
Corneal scar not easily distinguishable from current ulcer
Use of a topical steroid in the affected eye during the course of the present ulcer, including use after the symptoms of the ulcer started but before presentation
Use of systemic prednisolone during the course of the present ulcer
Age less than 16 years (before 16th birthday)
Bilateral ulcers
Previous penetrating keratoplasty
Pregnancy (by history or urine test)
Immediate steroid use necessary due to surgery or other condition

At Enrollment:

Evidence of fungus on culture at time of enrollment
Absence of bacteria on blood or chocolate agar culture
Best spectacle-corrected vision worse than 6/60 in the fellow eye
Corneal perforation or descemetocele
Known allergy to study medications (steroid or preservative)
No light perception in the affected eye
Not willing to come to follow-up visits
Not willing to participate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00324168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.