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OpenTrials
Completed

NCT Number: NCT00759148

Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%

Drug

Eye drops

Moxifloxacin AF Vehicle

Other

Inactive ingredients used as a placebo for masking purposes

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 25, 2008
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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