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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00629590
Other study ID # 041-106
Secondary ID P08649
Status Completed
Phase Phase 4
First received February 21, 2008
Last updated September 20, 2011
Start date March 2008

Study information

Verified date September 2011
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days

Locations

Country Name City State
United States South Shore Eye Care Wantagh New York

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in clinical signs and symptoms associated with blepharitis 2 weeks No
Secondary Standard ocular safety assessments 2 weeks No
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