A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00509873

Purpose

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: Gatifloxacin 0.5% eye drops Drug: placebo eye drops	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Tetrahydrozoline Gatifloxacin Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).

Secondary Outcome Measures:

Percentage of Patients With Microbiological Cure at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 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)
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis

Enrollment:	578
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gatifloxacin 0.5% Eye Drops Gatifloxacin 0.5% Eye Drops	Drug: Gatifloxacin 0.5% eye drops Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Placebo Comparator: Placebo Eye Drops Placebo Eye Drops	Drug: placebo eye drops Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

Signs and/or symptoms of conjunctivitis for more than 96 hours
Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
Clinical diagnosis of chlamydia in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509873

Locations

United States, Louisiana

Gretna, Louisiana, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00509873 History of Changes
Other Study ID Numbers:	198782-004
Study First Received:	July 30, 2007
Results First Received:	June 15, 2010
Last Updated:	October 24, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Tetrahydrozoline
Gatifloxacin
Fluoroquinolones
Nasal Decongestants
Vasoconstrictor Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Infective Agents
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012