You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 12, 2024

CLINICAL TRIALS PROFILE FOR AZASITE


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Azasite

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 Azasite

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00105469 ↗ Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) Completed Merck Sharp & Dohme Corp. Phase 3 2004-07-01 The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
NCT00105534 ↗ Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) Completed Merck Sharp & Dohme Corp. Phase 3 2004-07-01 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.
NCT00564447 ↗ Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers Completed Merck Sharp & Dohme Corp. Phase 4 2007-12-01 The purpose of this study is to evaluate the drug concentrations of AzaSiteā„¢ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Azasite

Condition Name

Condition Name for Azasite
Intervention Trials
Blepharitis 8
Eye Infections 3
Bacterial Infections 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Azasite
Intervention Trials
Blepharitis 8
Conjunctivitis 4
Infections 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Azasite

Trials by Country

Trials by Country for Azasite
Location Trials
United States 90
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Azasite
Location Trials
New York 9
Florida 6
California 6
Kentucky 5
Texas 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Azasite

Clinical Trial Phase

Clinical Trial Phase for Azasite
Clinical Trial Phase Trials
Phase 4 8
Phase 3 6
Phase 2 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Azasite
Clinical Trial Phase Trials
Completed 14
Withdrawn 2
Terminated 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Azasite

Sponsor Name

Sponsor Name for Azasite
Sponsor Trials
Merck Sharp & Dohme Corp. 10
InSite Vision 3
Sun Pharma Global FZE 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Azasite
Sponsor Trials
Industry 17
Other 6
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.