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Sponsors and Collaborators: |
University of California, San Francisco Aravind Eye Hospitals, India Dartmouth-Hitchcock Medical Center |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00324168 |
The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
Condition | Intervention | Phase |
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Corneal Ulcer Eye Infections, Bacterial |
Drug: Antibiotics Drug: Topical corticosteroid Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Steroids for Corneal Ulcers Trial |
Estimated Enrollment: | 500 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Antibiotics
moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization
Drug: Topical corticosteroid
prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week
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2: Placebo Comparator |
Drug: Antibiotics
moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization
Drug: Placebo
0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week
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Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection. However, "successful" treatment is not always associated with a good visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. Some corneal specialists advocate the use of topical corticosteroids along with antibiotics in an effort to reduce immune-mediated tissue damage and scarring. Others fear using steroids to reduce the cornea's immune response will prolong or even exacerbate infection. Ophthalmologists have been divided on this issue for more than 30 years, and both approaches are acceptable according to the American Academy of Ophthalmology's Preferred Practice Patterns. Evidence from animal and human reports is mixed. A single randomized trial saw a non-significant benefit to steroids but was drastically underpowered (20 patients per study arm).
The study is a randomized, double-masked, placebo-controlled trial to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers. Five hundred bacterial corneal ulcers presenting to the Aravind Eye Hospitals, the UCSF Proctor Foundation, and the Dartmouth- Hitchcock Medical Center are being randomized to receive antibiotic plus steroid or antibiotic plus placebo. They are being followed closely until re- epithelialization and then rechecked at three weeks, three months and 12 months post enrollment. The primary outcome is best spectacle-corrected logMAR visual acuity three months after enrollment, using best spectacle-corrected enrollment visual acuity as a co-variate.
The pilot study was conducted from January, 2005 to August, 2005 at Aravind Eye Hospital to assess the feasibility and safety and to estimate the sample size of a larger main trial. 42 patients with culture-proven bacterial keratitis were enrolled. They were treated and followed up as in the main trial, up to 3 months from enrollment.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
At Presentation:
At Enrollment:
Exclusion Criteria
At Presentation:
At Enrollment:
Contact: Tom Lietman, M.D. | (415) 502-2662 | tom.lietman@ucsf.edu |
United States, California | |
Proctor Foundation, UCSF | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Kevin Hong 415-514-2163 kevin.hong@ucsf.edu | |
Contact: Jenafir House, MPH, MSW (415) 514-1616 jenafir.house@ucsf.edu | |
Principal Investigator: Tom Lietman, MD | |
Sub-Investigator: John P Whitcher, MD, MPH | |
Sub-Investigator: Nisha Acharya, MD | |
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Contact: Christine Toutain, PhD 603-653-3178 Christine.M.Toutain@Dartmouth.EDU | |
Principal Investigator: Mike Zegans, MD | |
India, Tamil Nadu | |
Aravind Eye Hospital | Recruiting |
Madurai, Tamil Nadu, India, 625 020 | |
Contact: S Chandravathi +91 (452) 535-6100 childreneye@aravind.org | |
Contact: R Mahalakshmi +91 (452) 535-6100 eyebank@aravind.org | |
Principal Investigator: M. Srinivasan, MS, DO | |
Aravind Eye Hospital | Recruiting |
Tirunelveli, Tamil Nadu, India | |
Contact: S Chandravathi +91 (452) 535-6100 childreneye@aravind.org | |
Contact: M Meena lasik@tvl.aravind.org | |
Principal Investigator: M. Srinivasan, MS, DO | |
Aravind Eye Hospital | Recruiting |
Coimbatore, Tamil Nadu, India | |
Contact: R Revathi, MD +91 (422) 436-0400 revathi@cbe.aravind.org | |
Principal Investigator: M Srinivasan, MD |
Principal Investigator: | 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 |
Study Director: | Thomas M Lietman, M.D. | Proctor Foundation, UCSF |
Responsible Party: | Proctor Foundation, UCSF ( Thomas Lietman, MD, Principle Investigator ) |
Study ID Numbers: | H9332-21899-05, U10-EY015114-01 |
Study First Received: | May 5, 2006 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00324168 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Bacterial Infections Eye Diseases Bacterial Keratitis Visual Acuity |
Bacterial Infections Eye Infections, Bacterial Corneal Diseases Methylprednisolone Ulcer Eye Diseases Eye Infections |
Methylprednisolone acetate Prednisolone acetate Moxifloxacin Prednisolone Corneal Ulcer Keratitis Methylprednisolone Hemisuccinate |
Pathologic Processes Infection |