Status:
WITHDRAWN
Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Blepharoconjunctivitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00754949
Last Update
November 22 2021
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