NCT00386958

Brief Summary

Bacterial corneal ulcers are a leading cause of pediatric blindness in underdeveloped countries due to a lack of antibiotic availability and affordability, among other reasons. Povidone-iodine, an inexpensive and readily available broad-spectrum antimicrobial agent, may be an effective and affordable treatment for corneal ulcers, allowing preservation of sight for those afflicted with this disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
Last Updated

August 23, 2016

Status Verified

October 1, 2006

Enrollment Period

3.2 years

First QC Date

October 11, 2006

Last Update Submit

August 22, 2016

Conditions

Infected Corneal UlcersBacterial KeratitisCorneal UlcerChildhood Blindness

Keywords

corneal ulcersbacterial keratitischildhood blindnesspovidone-iodine

Outcome Measures

Primary Outcomes (2)

  • Days to cure, with corneal epithelial defect closed, and no inflammatory signs other than minimal injection.

  • Safety of study medication use compared to control medications. No untoward reactions or loss of visual acuity (VA) compared with pre-treatment VA findings.

Interventions

Povidone-IodineDRUG

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of untreated bacterial corneal ulcer that began within 14 days of presentation to the study center.
  • Corneal ulcer size is 2 mm-8 mm. in diameter, and does not extend to the limbus.

You may not qualify if:

  • Topical or systemic antimicrobial or immunosuppressant therapy within 14 days of presentation to the study center.
  • Corneal ulcer smear and culture fail to show the presence of bacteria.
  • Allergic history to povidone-iodine, iodine or any components of Neosporin.
  • Dacrocystitis, neurotropic or exposure keratitis, keratitis sicca, positive HIV status, and legal blindness in the unaffected eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (6)

  • Isenberg SJ, Apt L, Yoshimori R, Pham C, Lam NK. Efficacy of topical povidone-iodine during the first week after ophthalmic surgery. Am J Ophthalmol. 1997 Jul;124(1):31-5. doi: 10.1016/s0002-9394(14)71640-x.

    PMID: 9222229BACKGROUND

  • Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.

    PMID: 7040461BACKGROUND

  • Benevento WJ, Murray P, Reed CA, Pepose JS. The sensitivity of Neisseria gonorrhoeae, Chlamydia trachomatis, and herpes simplex type II to disinfection with povidone-iodine. Am J Ophthalmol. 1990 Mar 15;109(3):329-33. doi: 10.1016/s0002-9394(14)74560-x.

    PMID: 2155533BACKGROUND

  • Holderman LV, Cato EP, Moore WEC. Anaerobe Laboratory Manual. Blacksburg, Virginia. VPI Anaerobic Laboratory, 1977

    BACKGROUND

  • Everett SL, Kowalski RP, Karenchak LM, Landsittel D, Day R, Gordon YJ. An in vitro comparison of the susceptibilities of bacterial isolates from patients with conjunctivitis and blepharitis to newer and established topical antibiotics. Cornea. 1995 Jul;14(4):382-7. doi: 10.1097/00003226-199507000-00006.

    PMID: 7671609BACKGROUND

  • HOGAN MJ, KIMURA SJ, THYGESON P. Signs and symptoms of uveitis. I. Anterior uveitis. Am J Ophthalmol. 1959 May;47(5 Pt 2):155-70. doi: 10.1016/s0002-9394(14)78239-x. No abstract available.

    PMID: 13649855BACKGROUND

MeSH Terms

Conditions

Corneal Ulcer

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sherwin J. Isenberg, M.D.

    Jules Stein Eye Institute and Harbor-UCLA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 12, 2006

Study Start

November 1, 2002

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

August 23, 2016

Record last verified: 2006-10

Locations

US(1)