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

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Blepharoconjunctivitis

Treatments: Drug: 1% Azithromycin and 0.1% Dexamethasone; Drug: 0.1% Dexamethasone; Drug: 1% Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578955

C-07-502-002

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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417 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: 1% Azithromycin and 0.1% Dexamethasone

2

Active Comparator group

Treatment:

Drug: 1% Azithromycin

3

Active Comparator group

Treatment:

Drug: 0.1% Dexamethasone