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

Blepharoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00754949
• Other study ID #: C-07-502-003
• Status: Withdrawn
• Phase: Phase 3

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoconjunctivitis
• Conjunctivitis

Intervention

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.
• 1% Azithromycin
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
• 0.1% Dexamethasone
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of the clinical signs and symptoms.		2 weeks
Secondary	Bacterial eradication		2 weeks