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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT00578955
First received: December 19, 2007
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Blepharoconjunctivitis
Drug: 1% Azithromycin and 0.1% Dexamethasone
Drug: 1% Azithromycin
Drug: 0.1% Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • The resolution of the clinical signs and symptoms. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacterial eradication [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: December 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT00578955     History of Changes
Other Study ID Numbers: C-07-502-002
Study First Received: December 19, 2007
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by InSite Vision:
Blepharoconjunctivitis, Ophthalmology

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Azithromycin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on July 23, 2014