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

Information source: InSite Vision
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blepharoconjunctivitis

Intervention: 1% Azithromycin and 0.1% Dexamethasone (Drug); 1% Azithromycin (Drug); 0.1% Dexamethasone (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: InSite Vision

Overall contact:
Aron Shapiro, Phone: 866-393-3767, Ext: 243, Email: ashapiro@oraclinical.com

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Resolution of the clinical signs and symptoms.

Secondary outcome: Bacterial eradication

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Aron Shapiro, Phone: 866-393-3767, Ext: 243, Email: ashapiro@oraclinical.com

Additional Information

Starting date: November 2008
Last updated: October 29, 2008

Page last updated: October 04, 2010

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