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Sponsored by: |
InSite Vision |
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Information provided by: | InSite Vision |
ClinicalTrials.gov Identifier: | NCT00754949 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
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 |
Estimated Enrollment: | 399 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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.
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2: Active Comparator |
Drug: 1% Azithromycin
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
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3: Active Comparator |
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.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aron Shapiro | 866-393-3767 ext 243 | ashapiro@oraclinical.com |
Responsible Party: | Insite Vision Inc. ( Judith Hutcheson / Manager ) |
Study ID Numbers: | C-07-502-003 |
Study First Received: | September 16, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00754949 |
Health Authority: | United States: Food and Drug Administration; India: Drugs Controller General of India |
Blepharoconjunctivitis, Ophthalmology |
Dexamethasone Azithromycin Eye Diseases |
Conjunctivitis Dexamethasone acetate Conjunctival Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Anti-Bacterial Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |