Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

This study has been completed.

Study NCT00611403 Information provided by Allergan

First Received on January 28, 2008. Last Updated on November 17, 2011 History of Changes

Results First Received: November 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Dry Eye Syndromes
Interventions:	Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) Drug: Artificial Tears REFRESH ENDURA®

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
RESTASIS®	Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®	Artificial Tears (REFRESH ENDURA®)

Participant Flow for 2 periods

Period 1: Treatment Phase

	RESTASIS®	REFRESH ENDURA®
STARTED	68	69
COMPLETED	62	58
NOT COMPLETED	6	11

Period 2: Post Treatment Extension Phase

	RESTASIS®	REFRESH ENDURA®
STARTED	26 ^[1]	25 ^[2]
COMPLETED	22	24
NOT COMPLETED	4	1

[1]	26 of 68 pts who received RESTASIS® in the Treatment Phase entered the Post Treatment Ext. Phase
[2]	25 of 69 pts who received ENDURA® in the Treatment Phase entered the Post Treatment Extension Phase

Baseline Characteristics

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Reporting Groups

	Description
RESTASIS®	Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®	Artificial Tears (REFRESH ENDURA®)

Baseline Measures

	RESTASIS®	REFRESH ENDURA®	Total
Number of Participants [units: participants]	68	69	137
Age, Customized [units: participants]
< 30 years	19	21	40
Between 30 and 40 years	25	24	49
> 40 years	24	24	48
Gender [units: participants]
Female	43	36	79
Male	25	33	58

Outcome Measures

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1. Primary:

Percentage of Patients With Clinical Success at Month 6 [ Time Frame: Month 6 ]

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2. Secondary:

Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 [ Time Frame: Baseline, Month 6 ]

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3. Secondary:

Change From Baseline in Goblet Cell Density of the Eyes at Month 6 [ Time Frame: Baseline, Month 6 ]

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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:	NCT00611403 History of Changes
Other Study ID Numbers:	192371-014
Study First Received:	January 28, 2008
Results First Received:	November 17, 2011
Last Updated:	November 17, 2011
Health Authority:	United States: Food and Drug Administration