Expired Study
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Wantagh, New York 11793


Purpose:

The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic solution, 1% on signs and symptoms of blepharitis.


Criteria:

Inclusion Criteria: - diagnosis of moderate to severe chronic posterior blepharitis - if female of childbearing potential, are non-pregnant and non-lactating Exclusion Criteria: - had ocular surface surgery (LASIK, refractive, etc.) within the past year - unwilling to discontinue use of contact lenses during the study - have glaucoma - unable or unwilling to withhold the use of lid scrubs during the study - have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance - currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation


Study is Available At:


Original ID:

041-106


NCT ID:

NCT00629590


Secondary ID:


Study Acronym:


Brief Title:

Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis


Official Title:

A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Two Weeks in Subjects With Posterior Blepharitis


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Inspire Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Reza Haque
Study Director
works for Sponsor

Study Dates

Start Date:March 2008
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:November 2009
Last Changed Date:November 13, 2009
First Received Date:February 21, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in clinical signs and symptoms associated with blepharitis
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Standard ocular safety assessments
Time Frame:2 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:AzaSite®
Description:ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days
Arm Name:1
Other Name:AzaSite

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:No Intervention
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Inspire Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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