Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT01010633

First received: November 6, 2009

Last updated: December 8, 2011

Last verified: December 2011

History of Changes

Results First Received: August 30, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Inflammation Pain
Interventions:	Drug: Vehicle of Loteprednol Etabonate Drug: Loteprednol Etabonate

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
This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.

Reporting Groups

	Description
Loteprednol	Loteprednol etabonate 0.5%
Vehicle	Vehicle of loteprednol etabonate

Participant Flow: Overall Study

	Loteprednol	Vehicle
STARTED	203	203
COMPLETED	199	198
NOT COMPLETED	4	5
Adverse Event	1	1
Protocol Violation	1	2
Withdrawal by Subject	2	1
Investigator decision	0	1

Baseline Characteristics

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Reporting Groups

	Description
Loteprednol	Loteprednol etabonate 0.5%
Vehicle	Vehicle of loteprednol etabonate
Total	Total of all reporting groups

Baseline Measures

	Loteprednol	Vehicle	Total
Number of Participants [units: participants]	203	203	406
Age [units: years] Mean ± Standard Deviation	69.3 ± 8.73	69.0 ± 9.80	69.1 ± 9.27
Gender [units: participants]
Female	109	122	231
Male	94	81	175
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	0	1	1
Asian	2	3	5
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	20	16	36
White	176	182	358
Other	4	1	5

Outcome Measures

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1. Primary:

Resolution of Anterior Chamber Cells (ACC). [ Time Frame: Visit 5 (Postoperative day 8) ]

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2. Primary:

Grade 0 Pain [ Time Frame: Visit 5 (Postoperative Day 8) ]

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3. Secondary:

Resolution of Anterior Chamber Cells. [ Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18 ]

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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: All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.

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
No text entered.

Results Point of Contact:

Name/Title: Tuyen Ong, MD, MRCOphth
Organization: Bausch & Lomb Incorporated
phone: (973) 360-6389
e-mail: tuyen.ong@bausch.com

No publications provided

Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT01010633 History of Changes
Other Study ID Numbers:	576
Study First Received:	November 6, 2009
Results First Received:	August 30, 2011
Last Updated:	December 8, 2011
Health Authority:	United States: Food and Drug Administration

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