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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT00509873

First received: July 30, 2007

Last updated: October 24, 2011

Last verified: October 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	Gatifloxacin 0.5% eye drops
Placebo Eye Drops	Placebo eye drops

Participant Flow: Overall Study

	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
STARTED	287	291
COMPLETED	276	276
NOT COMPLETED	11	15

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Gatifloxacin 0.5% Eye Drops	Gatifloxacin 0.5% eye drops
Placebo Eye Drops	Placebo eye drops
Total	Total of all reporting groups

Baseline Measures

	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops	Total
Number of Participants [units: participants]	287	291	578
Age, Customized [units: participants]
1-18 years	123	123	246
19-65 years	126	141	267
>65 years	38	27	65
Gender [units: participants]
Female	161	172	333
Male	126	119	245

Outcome Measures

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1. Primary:

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

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2. Secondary:

Percentage of Patients With Microbiological Cure at Day 6 [ Time Frame: Day 6 ]

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3. Secondary:

Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6 [ Time Frame: Day 6 ]

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4. Secondary:

Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6 [ Time Frame: Day 6 ]

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5. Post-Hoc:

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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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

Results Point of Contact:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.

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

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