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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199510
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Alcon Research

Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Cataract Surgery Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care Other: Standard of Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: Systane

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

Active Comparator: Standard of Care only
Post Cataract Standard of Care Regimen
Other: Standard of Care
Post Cataract Surgery Standard of Care

Primary Outcome Measures :
  1. Ocular Comfort [ Time Frame: 30 days ]
    Ocular comfort will be reported by the patient on a questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Publications of Results:

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Responsible Party: Alcon Research Identifier: NCT01199510     History of Changes
Other Study ID Numbers: SMA-09-05
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: January 2012
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions