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

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ClinicalTrials.gov Identifier: NCT01199510
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 13, 2010
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2011)
Ocular Comfort [ Time Frame: 30 days ]
Ocular comfort will be reported by the patient on a questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Ocular Comfort Questionnaire (patient reported) [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT01199510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye
  • Cataract Surgery
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * http://www.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01199510
Other Study ID Numbers  ICMJE SMA-09-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date January 2012

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