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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR POVIDONE-IODINE

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505(b)(2) Clinical Trials for Povidone-iodine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01560962 Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis Terminated Southern California Institute for Research and Education N/A 2012-01-01 Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Povidone-iodine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00136344 Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery Completed Santen Gmbh N/A 2003-09-01 Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00136344 Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery Completed The European Society of Cataract and Refractive Surgeons(ESCRS) N/A 2003-09-01 Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00136344 Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery Completed City, University of London N/A 2003-09-01 Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00223002 Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient Completed University of Saskatchewan N/A 2004-11-01 Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill. This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour.
NCT00231153 Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters Completed Mallinckrodt Phase 3 2005-08-01 The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Povidone-iodine

Condition Name

Condition Name for Povidone-iodine
Intervention Trials
Surgical Site Infection 12
Endophthalmitis 5
Bacteremia 4
Wound Infection 3
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Condition MeSH

Condition MeSH for Povidone-iodine
Intervention Trials
Infection 23
Surgical Wound Infection 17
Communicable Diseases 13
Endophthalmitis 6
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Clinical Trial Locations for Povidone-iodine

Trials by Country

Trials by Country for Povidone-iodine
Location Trials
United States 51
Egypt 9
France 6
Canada 6
Germany 6
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Trials by US State

Trials by US State for Povidone-iodine
Location Trials
Illinois 5
New York 5
California 4
Massachusetts 4
Texas 4
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Clinical Trial Progress for Povidone-iodine

Clinical Trial Phase

Clinical Trial Phase for Povidone-iodine
Clinical Trial Phase Trials
Phase 4 37
Phase 3 17
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Povidone-iodine
Clinical Trial Phase Trials
Completed 45
Recruiting 26
Not yet recruiting 21
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Clinical Trial Sponsors for Povidone-iodine

Sponsor Name

Sponsor Name for Povidone-iodine
Sponsor Trials
Assiut University 5
Cairo University 3
Poitiers University Hospital 3
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Sponsor Type

Sponsor Type for Povidone-iodine
Sponsor Trials
Other 162
Industry 8
U.S. Fed 3
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