Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

Blepharoconjunctivitis Clinical Trial

Official title:

A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578955
• Other study ID #: C-07-502-002
• Status: Completed
• Phase: Phase 3
• Start date: December 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Have a clinical diagnosis of blepharoconjunctivitis
• Must be willing to discontinue contact lens wear for the duration of the study
• Additional inclusion criteria also apply.

Exclusion Criteria:

• Have known sensitivity or poor tolerance to any component of the study medications.
• Have any clinically significant cardiovascular disorders
• Have any history of liver or kidney disease resulting in persisting dysfunction
• Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
• Additional exclusion criteria also apply.

Related Conditions & MeSH terms

• Blepharoconjunctivitis
• Conjunctivitis

Intervention

Drug:
• 1% Azithromycin and 0.1% Dexamethasone
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
• 1% Azithromycin
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
• 0.1% Dexamethasone
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The resolution of the clinical signs and symptoms.		2 weeks
Secondary	Bacterial eradication		2 weeks