Study of Cyclosporine in Post-LASIK Patients

NCT ID: NCT00991458

Last Updated: 2013-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

621 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.

Detailed Description

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Conditions

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Laser In Situ Keratomileusis

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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Cyclosporine 0.010% eye drops

Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Group Type EXPERIMENTAL

Cyclosporine 0.010% eye drops

Intervention Type DRUG

Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Cyclosporine 0.005% eye drops

Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Group Type EXPERIMENTAL

Cyclosporine 0.005% eye drops

Intervention Type DRUG

Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Placebo (Vehicle for Cyclosporine)

Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Group Type PLACEBO_COMPARATOR

Placebo (Vehicle for Cyclosporine)

Intervention Type DRUG

Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Interventions

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Cyclosporine 0.010% eye drops

Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Intervention Type DRUG

Cyclosporine 0.005% eye drops

Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

Intervention Type DRUG

Placebo (Vehicle for Cyclosporine)

Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-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
* Previous use of RESTASIS®
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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192371-018

Identifier Type: -

Identifier Source: org_study_id

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