Skip to main content
OpenTrials
Completed

NCT Number: NCT00464438

A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Infections

Age range

Up to 31 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Whitby, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed with bacterial conjunctivitis

Exclusion criteria

  • chemical or foreign body trauma to either eye
  • infection in either eye (besides bacterial conjunctivitis)
  • white spots in the cornea or ulcers in either eye
  • clinical diagnosis of chlamydia or gonorrhea in either eye

Treatment and study plan

Gatifloxacin

Drug

Day 1-6 = 1 drop of study medication three times a day

Other names: Zymar®

moxifloxacin 0.5% eye drops

Drug

Day 1-6 = 1 drop of study medication three times a day

Other names: Vigamox®

Primary outcomes

  1. Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7

    Time frame: Day 7

    Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).

Secondary outcomes

  1. Percentage of Patients With Microbiological Improvement

    Time frame: Day 7

    Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).

  2. Percentage of Patients With Improvement in Ocular Signs for Lid Erythema

    Time frame: Days 7

    Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).

  3. Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7

    Time frame: Day 7

    Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,

    +3=severe).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 23, 2007
Registry last updated
Sep 21, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.