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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
InSite Vision
ClinicalTrials.gov Identifier:
NCT00754949
First received: September 16, 2008
Last updated: March 3, 2014
Last verified: March 2014
  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
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:
  • 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: 0
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:   12 Years 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
  • 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
  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: Judith Hutcheson / Manager, Insite Vision Inc.
ClinicalTrials.gov Identifier: NCT00754949     History of Changes
Other Study ID Numbers: C-07-502-003
Study First Received: September 16, 2008
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

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 August 28, 2014