Steroids for Corneal Ulcers Trial

NCT00324168 | Completed Phase 4 Results DMC

• 2 other identifiers: H9332-21899-05U10EY015114-01
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Corneal Ulcer; Eye Infections, Bacterial

Keywords

Bacterial Infections; Eye Diseases; Bacterial Keratitis; Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate

  LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.

  3 months from enrollment

Secondary Outcomes (10)

• Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment

  3 months from enrollment

• Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment

  3 months from enrollment

• Time to Resolution of Epithelial Defect

  From enrollment up to 21 days

• Ocular Perforations

  At the time of perforation

• Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate

  12 months from enrollment

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Antibiotics; Drug: Topical corticosteroid

2

PLACEBO COMPARATOR

Drug: Antibiotics; Drug: Placebo

Interventions

Antibiotics DRUG

moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization

Also known as: Vigamox

1; 2

Topical corticosteroid DRUG

prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week

1

Placebo DRUG

0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Thomas M. Lietman: lead
• Aravind Eye Hospitals, India: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (5)

Proctor Foundation, UCSF

San Francisco, California, 94143, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Aravind Eye Hospital

Coimbatore, Tamil Nadu, India

Location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

Location

Aravind Eye Hospital

Tirunelveli, Tamil Nadu, India

Location

Related Publications (13)

• Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Glidden DV, Ray KJ, Hong KC, Oldenburg CE, Lee SM, Zegans ME, McLeod SD, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group. The steroids for corneal ulcers trial: study design and baseline characteristics. Arch Ophthalmol. 2012 Feb;130(2):151-7. doi: 10.1001/archophthalmol.2011.303. Epub 2011 Oct 10.

  PMID: 21987581 BACKGROUND

• Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Glidden DV, Ray KJ, Hong KC, Oldenburg CE, Lee SM, Zegans ME, McLeod SD, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group. Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT). Arch Ophthalmol. 2012 Feb;130(2):143-50. doi: 10.1001/archophthalmol.2011.315. Epub 2011 Oct 10.

  PMID: 21987582 RESULT

• Hammond JH, Hebert WP, Naimie A, Ray K, Van Gelder RD, DiGiandomenico A, Lalitha P, Srinivasan M, Acharya NR, Lietman T, Hogan DA, Zegans ME. Environmentally Endemic Pseudomonas aeruginosa Strains with Mutations in lasR Are Associated with Increased Disease Severity in Corneal Ulcers. mSphere. 2016 Sep 7;1(5):e00140-16. doi: 10.1128/mSphere.00140-16. eCollection 2016 Sep-Oct.

  PMID: 27631025 DERIVED

• McClintic SM, Prajna NV, Srinivasan M, Mascarenhas J, Lalitha P, Rajaraman R, Oldenburg CE, O'Brien KS, Ray KJ, Acharya NR, Lietman TM, Keenan JD. Visual outcomes in treated bacterial keratitis: four years of prospective follow-up. Invest Ophthalmol Vis Sci. 2014 May 2;55(5):2935-40. doi: 10.1167/iovs.14-13980.

  PMID: 24618327 DERIVED

• Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Ray KJ, Zegans ME, Acharya NR, Lietman TM, Keenan JD; Steroids for Corneal Ulcers Trial Group. Visual recovery in treated bacterial keratitis. Ophthalmology. 2014 Jun;121(6):1310-1. doi: 10.1016/j.ophtha.2013.12.041. Epub 2014 Mar 5.

  PMID: 24612976 DERIVED

• Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, O'Brien KS, Glidden DV, Ray KJ, Oldenburg CE, Zegans ME, Whitcher JP, McLeod SD, Porco TC, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group. The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial. Am J Ophthalmol. 2014 Feb;157(2):327-333.e3. doi: 10.1016/j.ajo.2013.09.025. Epub 2013 Oct 1.

  PMID: 24315294 DERIVED

• Oldenburg CE, Lalitha P, Srinivasan M, Manikandan P, Bharathi MJ, Rajaraman R, Ravindran M, Mascarenhas J, Nardone N, Ray KJ, Glidden DV, Acharya NR, Lietman TM. Moxifloxacin susceptibility mediates the relationship between causative organism and clinical outcome in bacterial keratitis. Invest Ophthalmol Vis Sci. 2013 Feb 28;54(2):1522-6. doi: 10.1167/iovs.12-11246.

  PMID: 23385795 DERIVED

• Ray KJ, Prajna L, Srinivasan M, Geetha M, Karpagam R, Glidden D, Oldenburg CE, Sun CQ, McLeod SD, Acharya NR, Lietman TM. Fluoroquinolone treatment and susceptibility of isolates from bacterial keratitis. JAMA Ophthalmol. 2013 Mar;131(3):310-3. doi: 10.1001/jamaophthalmol.2013.1718.

  PMID: 23307105 DERIVED

• Lalitha P, Srinivasan M, Rajaraman R, Ravindran M, Mascarenhas J, Priya JL, Sy A, Oldenburg CE, Ray KJ, Zegans ME, McLeod SD, Lietman TM, Acharya NR. Nocardia keratitis: clinical course and effect of corticosteroids. Am J Ophthalmol. 2012 Dec;154(6):934-939.e1. doi: 10.1016/j.ajo.2012.06.001. Epub 2012 Sep 5.

  PMID: 22959881 DERIVED

• Lalitha P, Srinivasan M, Manikandan P, Bharathi MJ, Rajaraman R, Ravindran M, Cevallos V, Oldenburg CE, Ray KJ, Toutain-Kidd CM, Glidden DV, Zegans ME, McLeod SD, Acharya NR, Lietman TM. Relationship of in vitro susceptibility to moxifloxacin and in vivo clinical outcome in bacterial keratitis. Clin Infect Dis. 2012 May;54(10):1381-7. doi: 10.1093/cid/cis189. Epub 2012 Mar 23.

  PMID: 22447793 DERIVED

• Dalmon C, Porco TC, Lietman TM, Prajna NV, Prajna L, Das MR, Kumar JA, Mascarenhas J, Margolis TP, Whitcher JP, Jeng BH, Keenan JD, Chan MF, McLeod SD, Acharya NR. The clinical differentiation of bacterial and fungal keratitis: a photographic survey. Invest Ophthalmol Vis Sci. 2012 Apr 2;53(4):1787-91. doi: 10.1167/iovs.11-8478.

  PMID: 22395880 DERIVED

• Sy A, Srinivasan M, Mascarenhas J, Lalitha P, Rajaraman R, Ravindran M, Oldenburg CE, Ray KJ, Glidden D, Zegans ME, McLeod SD, Lietman TM, Acharya NR. Pseudomonas aeruginosa keratitis: outcomes and response to corticosteroid treatment. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):267-72. doi: 10.1167/iovs.11-7840.

  PMID: 22159005 DERIVED

• Srinivasan M, Lalitha P, Mahalakshmi R, Prajna NV, Mascarenhas J, Chidambaram JD, Lee S, Hong KC, Zegans M, Glidden DV, McLeod S, Whitcher JP, Lietman TM, Acharya NR. Corticosteroids for bacterial corneal ulcers. Br J Ophthalmol. 2009 Feb;93(2):198-202. doi: 10.1136/bjo.2008.147298. Epub 2008 Oct 1.

  PMID: 18829631 DERIVED

MeSH Terms

Conditions

Corneal Ulcer; Eye Infections, Bacterial; Bacterial Infections; Eye Diseases

Interventions

Anti-Bacterial Agents; Moxifloxacin; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Thomas Lietman
• Organization: F.I. Proctor Foundation, University of Califonia, San Francisco

tom.lietman@ucsf.edu

415-502-2662

Study Officials

• M. Srinivasan, M.S., O.D.

  Aravind Eye Hospital

  PRINCIPAL INVESTIGATOR

• Mike Zegans, M.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Nisha Acharya, M.D., M.S.

  Proctor Foundation, UCSF

  PRINCIPAL INVESTIGATOR

• Thomas M Lietman, M.D.

  Proctor Foundation, UCSF

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 10, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 1, 2018
• Results First Posted: June 14, 2013

Record last verified: 2018-07

Locations

US (2); IN (3)