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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
First received: September 9, 2010
Last updated: January 31, 2012
Last verified: January 2012
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 Intervention Phase
Dry Eye
Cataract Surgery
Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Other: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Ocular Comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Ocular comfort will be reported by the patient on a questionnaire

Enrollment: 40
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01199510     History of Changes
Other Study ID Numbers: SMA-09-05 
Study First Received: September 9, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Diseases
Lens Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on May 23, 2016