CClinicalTrials.gg
CompletedNCT01199510Updated Nov 18, 2016

Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery

A Phase 4 interventional study of FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care and Standard of Care in Dry Eye and Cataract Surgery, 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
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.

02

Conditions studied

  • Dry Eye
  • Cataract Surgery

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

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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.

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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 be seeking routine cataract extraction with monofocal intraocular lens implantation

Exclusion criteria

Exclusion Criteria:

  • Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
  • Patients cannot have a history of hypersensitivity to any component of FID 112903.
  • Patients cannot have previous intraocular or corneal surgery or any planned within 30 days.
  • Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study.
  • Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy.
  • Patients cannot have a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure >25 millimeters mercury in either eye.
  • Patients cannot have a history and/or current evidence of the following: clinically significant corneal scarring, blepharitis or macular pathology in either eye, Herpes zoster or Herpes simplex keratitis.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Standard of Care plus FID 112903

    SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily

    Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care

  • Active comparator
    Standard of Care only

    Post Cataract Standard of Care Regimen

    Other: Standard of Care

Interventions

  • OtherFID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care

    Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively

  • OtherStandard of Care

    Post Cataract Surgery Standard of Care

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What researchers measure

Primary outcomes

  1. Ocular Comfort

    Ocular comfort will be reported by the patient on a questionnaire

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • http://www.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295
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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 ↗
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Registry details

Key details

Study ID
NCT01199510
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Sep 13, 2010
Start date
Sep 2010
Primary completion
Jun 2011
Completion
Jun 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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