A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

This study has been completed.

Study NCT00518089 Information provided by Allergan

First Received on August 16, 2007. Last Updated on October 24, 2011 History of Changes

Results First Received: June 15, 2010

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
Condition:	Bacterial Conjunctivitis
Interventions:	Drug: Gatifloxacin 0.5% eye drops Drug: placebo eye drops

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Gatifloxacin 0.5% Eye Drops	No text entered.
Placebo Eye Drops	No text entered.

Participant Flow: Overall Study

	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
STARTED	430	429
COMPLETED	402	398
NOT COMPLETED	28	31

Baseline Characteristics

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Reporting Groups

	Description
Gatifloxacin 0.5% Eye Drops	No text entered.
Placebo Eye Drops	No text entered.

Baseline Measures

	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops	Total
Number of Participants [units: participants]	430	429	859
Age, Customized [units: participants]
1-18 years	66	74	140
19-65 years	316	313	629
>65 years	48	42	90
Gender [units: participants]
Female	183	156	339
Male	247	273	520

Outcome Measures

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1. Primary:

Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 [ Time Frame: 6 Days ]

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2. Secondary:

Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 [ Time Frame: Day 6 ]

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3. Secondary:

Percentage of Patients With Microbiological Cure Up to Day 6 [ Time Frame: 6 Days ]

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4. Secondary:

Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6 [ Time Frame: 6 Days ]

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5. Secondary:

Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 [ Time Frame: 6 Days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: (714) 246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00518089 History of Changes
Other Study ID Numbers:	198782-005
Study First Received:	August 16, 2007
Results First Received:	June 15, 2010
Last Updated:	October 24, 2011
Health Authority:	United States: Food and Drug Administration