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

November 19, 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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

12 years and older (Child, Adult, Older Adult)

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
  • 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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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
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
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 Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-502-003

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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