Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

December 5, 2017 updated by: Alcon Research
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1179

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 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with bacterial conjunctivitis in 1 or both eyes;
  • Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
  • Agrees to comply with the visit schedule and other requirements of the study;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
  • Presence of concomitant viral infection;
  • Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
  • Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
  • Infants undergoing treatment for retinopathy of prematurity;
  • Contact lens wear during the course of the study;
  • Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
  • Use of medications, as specified in the protocol;
  • Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
  • Known or suspected allergy or hypersensitivity to fluoroquinolones;
  • Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
  • Other protocol-specified exclusion criteria may 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxifloxacin AF
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Eye drops
Placebo Comparator: Vehicle
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Other: Moxifloxacin AF Vehicle
Inactive ingredients used as a placebo for masking purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure at the Day 4 (EOT)/Exit Visit
Time Frame: Day 4
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
Day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological Success at the Day 4 (EOT)/Exit Visit
Time Frame: Day 4
Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Day 4

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Alcon Research, Ltd., Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-40

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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