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

November 18, 2021 updated by: Sun Pharmaceutical Industries Limited

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: 1% Azithromycin
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
Other Names:
  • AzaSite
EXPERIMENTAL: 1
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.
Other Names:
  • AzaSite Plus
ACTIVE_COMPARATOR: 3
Drug: 0.1% Dexamethasone
Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
Other Names:
  • Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The resolution of the clinical signs and symptoms.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacterial eradication
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (ESTIMATE)

December 21, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-502-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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