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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01198782
Other study ID # SMA-09-42
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2010
Last updated November 17, 2016
Start date September 2010
Est. completion date May 2011

Study information

Verified date January 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)
Patients will dose 4 times daily for 4 months.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary The change from baseline in Total Corneal Staining. 4 months No
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