Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
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ClinicalTrials.gov Identifier: NCT00578955 |
Recruitment Status :
Completed
First Posted : December 21, 2007
Last Update Posted : November 19, 2021
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Sponsor:
Sun Pharmaceutical Industries Limited
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blepharoconjunctivitis | Drug: 1% Azithromycin and 0.1% Dexamethasone Drug: 1% Azithromycin Drug: 0.1% Dexamethasone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 417 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |
Resource links provided by the National Library of Medicine

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
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.
Other Name: AzaSite Plus |
Active Comparator: 2 |
Drug: 1% Azithromycin
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
Other Name: AzaSite |
Active Comparator: 3 |
Drug: 0.1% Dexamethasone
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
Other Name: Dexamethasone |
Primary Outcome Measures :
- The resolution of the clinical signs and symptoms. [ Time Frame: 2 weeks ]
Secondary Outcome Measures :
- Bacterial eradication [ Time Frame: 2 weeks ]
Information from the National Library of Medicine

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Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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.
No Contacts or Locations Provided
Responsible Party: | Sun Pharmaceutical Industries Limited |
ClinicalTrials.gov Identifier: | NCT00578955 |
Other Study ID Numbers: |
C-07-502-002 |
First Posted: | December 21, 2007 Key Record Dates |
Last Update Posted: | November 19, 2021 |
Last Verified: | November 2021 |
Keywords provided by Sun Pharmaceutical Industries Limited:
Blepharoconjunctivitis, Ophthalmology |
Additional relevant MeSH terms:
Conjunctivitis Conjunctival Diseases Eye Diseases Azithromycin Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |