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

Sun Pharmaceutical Industries Limited417 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

417

Conditions

Blepharoconjunctivitis

Interventions

1% Azithromycin and 0.1% DexamethasoneDRUG

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

1% AzithromycinDRUG

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

0.1% DexamethasoneDRUG

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: * Have a clinical diagnosis of blepharoconjunctivitis * Must be willing to discontinue contact lens wear for the duration of the study * Additional inclusion criteria also apply. Exclusion Criteria: * Have known sensitivity or poor tolerance to any component of the study medications. * 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. * Additional exclusion criteria also apply.

Outcomes

Primary Outcomes

The resolution of the clinical signs and symptoms.

Time frame: 2 weeks

Secondary Outcomes

Bacterial eradication

Time frame: 2 weeks

Data from ClinicalTrials.gov

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