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

NCT ID: NCT00611403

Last Updated: 2011-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-06-30

Brief Summary

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This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Detailed Description

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Conditions

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Dry Eye Syndromes

Keywords

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LASIK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RESTASIS®

Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Group Type ACTIVE_COMPARATOR

Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Intervention Type DRUG

Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery

REFRESH ENDURA®

Artificial Tears (REFRESH ENDURA®)

Group Type ACTIVE_COMPARATOR

Artificial Tears REFRESH ENDURA®

Intervention Type DRUG

REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Interventions

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Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery

Intervention Type DRUG

Artificial Tears REFRESH ENDURA®

REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is scheduled for bilateral LASIK surgery
* Patient is in good general health
* Eye glasses prescription of -1 to -8

Exclusion Criteria

* Significant Dry Eye
* Presence of eye disease
* Uncontrolled systemic disease
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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192371-014

Identifier Type: -

Identifier Source: org_study_id