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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 : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
InSite Vision

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


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 :
  1. The resolution of the clinical signs and symptoms. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Bacterial eradication [ Time Frame: 2 weeks ]


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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.

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT00578955     History of Changes
Other Study ID Numbers: C-07-502-002
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by InSite Vision:
Blepharoconjunctivitis, Ophthalmology

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Azithromycin
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