Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516399
Status:
TERMINATED
Last Update Posted:
2014-12-04
First Post:
2007-08-14
Brief Title:
A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The DSMC decided it appeared futile to attempt to demonstrate non-inferiority of povidone-iodine to Natamycin
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of 125 povidone-iodine ophthalmic solution for the treatment of small to medium sized fungal corneal ulcers compared with an antifungal antibiotic
Detailed Description:
The medication to be studied is 125 povidone-iodine solution and the control medication is 5 natamycin ophthalmic suspension The povidone-iodine concentration of 125 was chosen based on a study using povidone-iodine ophthalmic solution for the first week after ocular surgery Initially some patients complained of a stinging sensation when using the 25 concentration This might prevent full compliance from some subjects When the solution was diluted to 125 there were no more complaints of discomfort Therefore in the actual one-week postoperative clinical trial the 125 concentration was used without any patient complaints and it was found to be effective In a pilot study conducted in the Philippines investigating treatment of small to medium-sized fungal corneal ulcers 125 povidone-iodine was shown to be effective against fungal corneal ulcers including those caused by Fusarium solani and Mycelia sterila when treated for 7-20 days
The povidone-iodine 125 solution will be prepared by removing 1875 ml of solution from a 15 ml bottle of Balanced Salt Solution BSS Alcon Laboratories Inc Fort Worth and inserting 1875 ml of a 10 povidone-iodine solution Betadine solution Purdue Frederick Norwalk Preparations will be made weekly for each subject using sterile technique and are to be stored in a cool dark place The control anti-fungal will be natamycin ophthalmic suspension USP 5 Natamet MJ Pharmaceuticals Ltd Mumbai India which represents the current standard of care The subjects will be discharged home on the same randomized medication that they were assigned while hospitalized
Prospective candidates for the study andor their parent or guardian will review the appropriate Human Subjects Consent Form approved by the Human Subjects Protection Committee of the Harbor-UCLA Medical Center After written consents Informed and HIPPA are obtained each subject will be randomized to receive either povidone-iodine or the control drug All subjects will be hospitalized for a minimum duration of 7 days for careful monitoring and appropriate treatment To assure compliance all these inpatient subjects will have their medications administered by medical personnel Upon admission the intake clinical examination will be recorded
Each infected eye will be randomly assigned by the research nurse to be treated with povidone-iodine 125 or the control anti-fungal medication natamycin Randomization will be achieved by using random number generated randomization schedules To guarantee similar distribution will occur and not be left to chance each study site randomization schedule will be stratified on ulcer sizes 3mm and 3mm
The only eye medications permitted beside povidone-iodine 125 ophthalmic solution and the control drug natamycin will be atropine ophthalmic solution to reduce intraocular inflammation and prevent synechiae and anti-glaucoma medication as needed The atropine will be administered to the affected eyes twice a day and strength will vary according to the subjects age Subjects less than 1 year of age will be given atropine 025 ages 1-3 will be given 05 and subjects greater than 3 years of age will be given 1
The dosing schedule of povidone-iodine 125 or control medication is as follows
1 For the first three days one drop of the medication will be applied every hour
2 Day 4 and thereafter hourly while awake when asleep every three hours Sleep is not to exceed 9 hours Treat all cases with intense drop therapy for a minimum of 5 days unless criteria for change in therapy are met
3 At 5 days decrease dosing frequency to every 2 hours while awake until cured only if no deterioration in any factor and improved in at least one factor other than epithelial defect is noted on 2 consecutive examinations
4 If at 10 days the status remains unchanged the subject is to exit the study
5 After discharge dosing frequency is to remain every 2 hours while awake until cured
The povidone-iodine 125 solution will be prepared by removing 1875 ml of solution from a 15 ml bottle of Balanced Salt Solution BSS Alcon Laboratories Inc Fort Worth and inserting 1875 ml of a 10 povidone-iodine solution Betadine solution Purdue Frederick Norwalk Preparations will be made weekly for each subject using sterile technique and are to be stored in a cool dark place The control anti-fungal will be natamycin ophthalmic suspension USP 5 Natamet MJ Pharmaceuticals Ltd Mumbai India which represents the current standard of care The subjects will be discharged home on the same randomized medication that they were assigned while hospitalized
Prospective candidates for the study andor their parent or guardian will review the appropriate Human Subjects Consent Form approved by the Human Subjects Protection Committee of the Harbor-UCLA Medical Center After written consents Informed and HIPPA are obtained each subject will be randomized to receive either povidone-iodine or the control drug All subjects will be hospitalized for a minimum duration of 7 days for careful monitoring and appropriate treatment To assure compliance all these inpatient subjects will have their medications administered by medical personnel Upon admission the intake clinical examination will be recorded
Each infected eye will be randomly assigned by the research nurse to be treated with povidone-iodine 125 or the control anti-fungal medication natamycin Randomization will be achieved by using random number generated randomization schedules To guarantee similar distribution will occur and not be left to chance each study site randomization schedule will be stratified on ulcer sizes 3mm and 3mm
The only eye medications permitted beside povidone-iodine 125 ophthalmic solution and the control drug natamycin will be atropine ophthalmic solution to reduce intraocular inflammation and prevent synechiae and anti-glaucoma medication as needed The atropine will be administered to the affected eyes twice a day and strength will vary according to the subjects age Subjects less than 1 year of age will be given atropine 025 ages 1-3 will be given 05 and subjects greater than 3 years of age will be given 1
The dosing schedule of povidone-iodine 125 or control medication is as follows
1 For the first three days one drop of the medication will be applied every hour
2 Day 4 and thereafter hourly while awake when asleep every three hours Sleep is not to exceed 9 hours Treat all cases with intense drop therapy for a minimum of 5 days unless criteria for change in therapy are met
3 At 5 days decrease dosing frequency to every 2 hours while awake until cured only if no deterioration in any factor and improved in at least one factor other than epithelial defect is noted on 2 consecutive examinations
4 If at 10 days the status remains unchanged the subject is to exit the study
5 After discharge dosing frequency is to remain every 2 hours while awake until cured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None