CClinicalTrials.gg
CompletedNCT01198782Updated Nov 18, 2016

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

A Phase 4 interventional study of FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) in Dry Eye Syndrome, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye Syndrome

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03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

    SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily

    Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

Interventions

  • OtherFID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)

    Patients will dose 4 times daily for 4 months.

06

What researchers measure

Primary outcomes

  1. The change from baseline in Total Corneal Staining.

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • http://iovs.arvojournals.org/article.aspx?articleid=2353102
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01198782
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Sep 10, 2010
Start date
Sep 2010
Primary completion
May 2011
Completion
May 2011
Last update
Nov 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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