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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01198782

Enrollment

Registered

2010-09-10

Start date

2010-09-30

Completion date

2011-05-31

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Brief summary

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.

Interventions

OTHERFID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

Patients will dose 4 times daily for 4 months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The change from baseline in Total Corneal Staining.	4 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026