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Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis - Article


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Conjunctivitis

Pink Eye; Pink eye (conjunctivitis)

Clinical Trial: Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis

This study is currently recruiting patients.

Sponsored by: InSite Vision
Information provided by: InSite Vision

Purpose

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

Condition Treatment or Intervention Phase
Bacterial Conjunctivitis
  Drug: AzaSite
 Phase III

MedlinePlus related topics:  Bacterial Infections;   Eye Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

Further Study Details: 
Primary Outcomes: Clinical assesments of ocular discharge; Bacteriological cultures
Secondary Outcomes: Adverse events; Visual acuity; Biomicroscopy; Ophthalmoscopy
Expected Total Enrollment:  600

Study start: July 2004;  Expected completion: August 2005
Last follow-up: June 2005;  Data entry closure: August 2005

Eligibility

Ages Eligible for Study:  12 Months and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Male or female subject, of any race, who is at least 1 year of age.
  • Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
  • The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
  • Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

  • Any uncontrolled, systemic, debilitating disease.
  • Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
  • Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
  • Any active upper respiratory tract infection.
  • Pregnant or nursing females.
  • Use of any antibiotic (topical or systemic) within 72 hours of enrollment

Location and Contact Information


Arizona
      I Care! Eye Care!, Flagstaff,  Arizona,  86001,  United States; Recruiting
Catherine Young  928-774-0322 
David McGarey, MD,  Principal Investigator

California
      North Bay Eye Associates, Petaluma and Santa Rosa,  California,  95401,  United States; Recruiting
Angela Lewis  707-769-2240 
Jason Bacharach, MD,  Principal Investigator

      Rx For Life, Inc., Cudahy,  California,  90201,  United States; Recruiting
Gisele Bautista  323-773-2180 
Casimiro Gonzalez, MD,  Principal Investigator

      San Diego Eye and Laser Center, San Diego,  California,  92123,  United States; Recruiting
Virginia Gains  858-278-9900 
Richard Leung, MD,  Principal Investigator

      Spectrum Eye Physicians, San Jose,  California,  95124,  United States; Recruiting
Gilda Perruzi  408-358-0017 
James Liu, M.D.,  Principal Investigator

      Sashta Eye Associates Center for Sight, Redding,  California,  96002,  United States; Recruiting
Becky Davenport  530-223-2500 
Bruce Silverstein, M.D.,  Principal Investigator

Colorado
      Western States Clinical Research, Wheat Ridge,  Colorado,  80033,  United States; Recruiting
Amber Bretz  303-940-9773 
Melinda O'Rourke, MD,  Principal Investigator

      Corneal Consultants of Colorado, P.C., Littleton,  Colorado,  80120,  United States; Recruiting
Michelle Schmitz  303-795-7341  Ext. 253 
S. Lance Forstot, M.D.,  Principal Investigator

Connecticut
      Opticare Eye Health Center, Waterbury,  Connecticut,  06708,  United States; Recruiting
Ann-Marie Cirkot  203-465-1232 
Vincent DeLuise, MD,  Principal Investigator

      The Eye Care Group, Waterbury,  Connecticut,  06708,  United States; Recruiting
Sue Heaton  203-597-9100 
Joel Geffin, M.D.,  Principal Investigator

Florida
      International Eye Center, Tampa,  Florida,  33603,  United States; Recruiting
Sandra Montoya  813-875-3937 
Don Perez-Ortiz, MD,  Principal Investigator

      Atlantic Eye Center, Palm Coast,  Florida,  32137,  United States; Recruiting
Ann Slager  386-446-9590 
Alexandra Kostick, M.D.,  Principal Investigator

Georgia
      Clayton Eye Center, Morrow,  Georgia,  30260,  United States; Recruiting
Helen DuBiner  770-968-8888 
Harvey B DuBiner, M.D.,  Principal Investigator

Indiana
      Welborn Clinic and Welborn Clinic East, Evansville,  Indiana,  47713,  United States; Recruiting
Kelly Roby  812-474-7189 
Andrew Tharp, MD,  Principal Investigator

Kentucky
      Taustine Eye Center, Louisville,  Kentucky,  40217,  United States; Recruiting
Mary Beth Gardner  502-458-0728  Ext. 5 
Robert Williams, MD,  Principal Investigator

      Dr. Richard Eiferman, Louisville,  Kentucky,  40205,  United States; Recruiting
Pam Durham  502-895-4200 
Richard Eiferman, M.D.,  Principal Investigator

      Kentucky Center for Vision, Lexington,  Kentucky,  40509,  United States; Recruiting
Leslie Cornette, COT  859-263-4631 
Bruce Koffler, M.D.,  Principal Investigator

      Kentucky Eye Care, P.S.C., Louisville,  Kentucky,  40205,  United States; Recruiting
Pamela Carter, COA  502-896-8700  Ext. 120 
C. Thomas Moran, M.D.,  Principal Investigator

Louisiana
      Bossier Optical Inc., Bossier City,  Louisiana,  71111,  United States; Recruiting
Cindy Henry  501-221-5000 
Yue-Kong Au, MD,  Principal Investigator

      Bohn and Joseph Eye Center, Lafayette,  Louisiana,  70506,  United States; Recruiting
Jan Pothier  337-984-7787 
Barry Bohn, MD,  Principal Investigator

      The Louisiana Eye Center, Zachary,  Louisiana,  70791,  United States; Recruiting
Donna Deshotels  225-757-1084  Ext. 373 
Angela Lewis, MD,  Principal Investigator

      Eyecare Associates, Metairie,  Louisiana,  70006,  United States; Recruiting
Cheryl Crouse  504-455-9825 
Donald Cerise, M.D.,  Principal Investigator

Massachusetts
      Andover Eye Associates, Andover,  Massachusetts,  01810,  United States; Recruiting
Janet Bonzagni  978-475-0705 
H. Jerome Crampton, M.D.,  Principal Investigator

Minnesota
      Eye Care Associates, PA, Minneapolis,  Minnesota,  55402,  United States; Recruiting
Kurt Schultz  612-436-2117 
Dinesh Goyal, M.D.,  Principal Investigator

Mississippi
      Mississippi Eye Associates, Ocean Springs,  Mississippi,  39564,  United States; Recruiting
John Schuhr  228-875-2020 
James Sutton, MD,  Principal Investigator

Missouri
      Silverstein Eye Centers, Kansas City,  Missouri,  64133,  United States; Recruiting
Cheryl Harper  816-358-3633  Ext. 241 
Steven M Silverstein, M.D.,  Principal Investigator

New Hampshire
      Eyesight Ophthalmic Services, P.A., Portsmouth,  New Hampshire,  03801,  United States; Recruiting
Teri Sandven  603-436-1773 
Ginny Standen  603-436-1773 
Richard Chace, M.D.,  Principal Investigator

New Jersey
      Clinical Research Laboratories, Piscataway,  New Jersey,  08854,  United States; Recruiting
Yang Gao  732-981-1616 
Bruce Kanengiser, MD,  Principal Investigator

      Advanced Eyecare and Laser Center, Runnemede,  New Jersey,  08078,  United States; Recruiting
Chuck Power  856-424-1777 
Michael Yaros, MD,  Principal Investigator

New York
      Precision Eye Care, Huntington,  New York,  11743,  United States; Recruiting
Barbara Reiss, OD  631-462-2020 
Richard Davis, MD,  Principal Investigator
Barbara Reiss, OD,  Sub-Investigator

      Rochester Ophthalmological Group, P.C., Rochester,  New York,  14618,  United States; Recruiting
Mindy VanVoorhis  585-244-6011  Ext. 314 
Missy Hart  585-244-6011  Ext. 315 
Howard Schenker, M.D.,  Principal Investigator

North Carolina
      Horizon Eye Center, Charlotte,  North Carolina,  28211,  United States; Recruiting
Mara-Leigh Schafer  704-367-8104 
Paul Galentine, MD,  Principal Investigator

      Groat Eyecare Associates, Greensboro,  North Carolina,  27401,  United States; Recruiting
Sharon Debnam  336-286-1194 
Robert Groat, MD,  Principal Investigator

      Charlotte Eye, Ear, Nose, and Throat, Charlotte,  North Carolina,  28210,  United States; Recruiting
Alison Stallings  704-295-3390 
Michael Rotberg, MD,  Principal Investigator

      James D. Branch, M.D., Winston Salem,  North Carolina,  27101,  United States; Recruiting
Catherine Revis, COA  336-723-0748 
James D Branch, M.D.,  Principal Investigator

Ohio
      Abrams Eye Center, Cleveland,  Ohio,  44115,  United States; Recruiting
Margaret Smith  216-937-2020 
Marc Abrams, MD,  Principal Investigator

Oregon
      Bend Memorial Clinic, Bend,  Oregon,  97701,  United States; Recruiting
Justin Wray  541-318-3137 
Brian Desmond, MD,  Principal Investigator

Tennessee
      Eye Associates, Nashville,  Tennessee,  37203,  United States; Recruiting
Debbie Shepard  615-844-1223 
James Felch, MD,  Principal Investigator

      Total Eye Care, PA, Memphis,  Tennessee,  38119,  United States; Recruiting
Jennifer Miller  901-761-4620 
Elizabeth Mitchell, MD,  Principal Investigator

      University Eye Surgeons, Maryville,  Tennessee,  37803,  United States; Recruiting
Marta Johnson  865-681-1234 
Kenneth Olander, MD,  Principal Investigator

Texas
      Sun Research Institute, San Antonio,  Texas,  78205,  United States; Recruiting
Clarrissa Chapa  210-227-1289 
Tomas Coronado, MD,  Principal Investigator

      Metaclin Research, Inc., Austin,  Texas,  78704,  United States; Recruiting
Rafael Cajigas  512-732-2444 
Thomas Henderson, MD,  Principal Investigator

      Physicians Eye Associates & Cosmetic Laser, Houston,  Texas,  77002,  United States; Recruiting
Mahmood Mehkri  832-606-2053 
Mustapha Kibirige, MD,  Principal Investigator

      Mark Mayo, MD, Pasadena,  Texas,  77504,  United States; Recruiting
Kay Smith  832-452-3618 
Mark Mayo, MD,  Principal Investigator

      Marc Sanders, MD, Houston,  Texas,  77030,  United States; Recruiting
Kay Smith  832-452-3618 
Marc Sanders, MD,  Principal Investigator

      Keystone, San Antonio,  Texas,  78240,  United States; Recruiting
Brian Mathews  210-696-9706 
Richard Evans, M.D.,  Principal Investigator

      Eye Clinics of South Texas, San Antonio,  Texas,  78209,  United States; Recruiting
Marcie Smith  210-826-2012 
Jay M Rubin, M.D.,  Principal Investigator

      David G. Shulman, M.D., P.A., San Antonio,  Texas,  78209,  United States; Recruiting
Deborah Lazar-Szochak  210-821-6901  Ext. 33 
David Shulman, M.D.,  Principal Investigator

Utah
      Mountain View Eye Center, Layton,  Utah,  84041,  United States; Recruiting
Lisa Bailey  801-390-8428 
Lamont Ericson, MD,  Principal Investigator

      Cottonwood Eye and Laser Clinic, Salt Lake City,  Utah,  84107,  United States; Recruiting
Lisa Brinkman  801-352-9228 
Alan Jackson, MD,  Principal Investigator

      Advanced Eye Care, Salt Lake City,  Utah,  84124,  United States; Recruiting
Mari Munoz  801-263-2020 
Francis J Wapner, M.D.,  Principal Investigator

Virginia
      Access Eye Research Centers, Fredericksburg,  Virginia,  22405,  United States; Recruiting
Lynn Haynes  540-371-2020  Ext. 23 
Jacqueline B. Mussellman-Baker  540-572-2149  Ext. 23 
Arash Mansouri, M.D.,  Principal Investigator

Wisconsin
      Advanced Healthcare, SC, Milwaukee,  Wisconsin,  53209,  United States; Recruiting
Mary Andrus  414-352-5161  Ext. 5373 
Douglas Long, MD,  Principal Investigator

More Information

http://www.insitevision.com

Study ID Numbers:  C-01-401-03
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 15, 2005
ClinicalTrials.gov Identifier:  NCT00105534
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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