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

Phase 3

Withdrawn

• Conditions: Blepharoconjunctivitis
• Interventions: Drug: 1% Azithromycin and 0.1% Dexamethasone; Drug: 1% Azithromycin; Drug: 0.1% Dexamethasone

• Registration Number: NCT00754949
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Have a clinical diagnosis of blepharoconjunctivitis
• Must be willing to discontinue contact lens wear for the duration of the study
• Have best corrected visual acuity of 6/24 in both eyes
• Have IOP less than or equal to 25 mmHg in either eye

Exclusion Criteria

• Have known sensitivity or poor tolerance to any component of the study medications
• Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months
• Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study
• Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment
• Use of any eye make-up during the study
• Have any uncontrolled systemic disease or debilitating disease
• Have been diagnosed with glaucoma
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	1% Azithromycin and 0.1% Dexamethasone	-
2	1% Azithromycin	-
3	0.1% Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Resolution of the clinical signs and symptoms.	2 weeks

Secondary Outcome Measures

Name	Time	Method
Bacterial eradication	2 weeks