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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01199510
First received: September 9, 2010
Last updated: January 31, 2012
Last verified: January 2012

September 9, 2010
January 31, 2012
September 2010
June 2011   (final data collection date for primary outcome measure)
Ocular Comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Ocular comfort will be reported by the patient on a questionnaire
Ocular Comfort Questionnaire (patient reported) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01199510 on ClinicalTrials.gov Archive Site
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Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Dry Eye
  • Cataract Surgery
  • 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
  • Other: Standard of Care
    Post Cataract Surgery Standard of Care
  • Experimental: Standard of Care plus FID 112903
    SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
    Intervention: Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
  • Active Comparator: Standard of Care only
    Post Cataract Standard of Care Regimen
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01199510
SMA-09-05
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP