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

This study has been completed.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00464438

First received: April 19, 2007

Last updated: August 17, 2011

Last verified: August 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 Drug: moxifloxacin 0.5% 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 0.3%	No text entered.
Moxifloxacin 0.5%	No text entered.

Participant Flow: Overall Study

	Gatifloxacin 0.3%	Moxifloxacin 0.5%
STARTED	85	86
COMPLETED	83	80
NOT COMPLETED	2	6

Baseline Characteristics

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Reporting Groups

	Description
Gatifloxacin 0.3%	No text entered.
Moxifloxacin 0.5%	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Gatifloxacin 0.3%	Moxifloxacin 0.5%	Total
Number of Participants [units: participants]	85	86	171
Age [units: days] Mean ± Standard Deviation	15.2 ± 6.59	15.2 ± 6.05	15.2 ± 6.31
Gender [units: participants]
Female	37	22	59
Male	48	64	112

Outcome Measures

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1. Primary:

Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 [ Time Frame: Day 7 ]

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2. Secondary:

Percentage of Patients With Microbiological Improvement [ Time Frame: Day 7 ]

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3. Secondary:

Percentage of Patients With Improvement in Ocular Signs for Lid Erythema [ Time Frame: Days 7 ]

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4. Secondary:

Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 [ Time Frame: Day 7 ]

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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:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00464438 History of Changes
Other Study ID Numbers:	198782-003
Study First Received:	April 19, 2007
Results First Received:	June 15, 2010
Last Updated:	August 17, 2011
Health Authority:	United States: Food and Drug Administration

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