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Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%

NCT ID: NCT01198782

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of RESTASIS.

Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily

Group Type EXPERIMENTAL

FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

Intervention Type OTHER

Patients will dose 4 times daily for 4 months.

Interventions

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FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

Patients will dose 4 times daily for 4 months.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must be at least 18 years of age
* Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, and must use Restasis BID for at least 6 months.
* Lastly, patients must have a sodium fluorescein (NaFl) corneal staining sum score of greater than or equal to 3 in the worse eye.

Exclusion Criteria

* Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 112903.
* Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have punctal plugs of any type.
* Patients cannot use any prescription topical medication for other ocular conditions (such as glaucoma, uveitis, etc).
* Patients cannot use systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit 1.
* Patients cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
* Patients cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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http://iovs.arvojournals.org/article.aspx?articleid=2353102

Reference Type RESULT

Other Identifiers

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SMA-09-42

Identifier Type: -

Identifier Source: org_study_id