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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

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

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 Eye Care
Drug Information available for: Systane
U.S. FDA Resources

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Alcon Research
ClinicalTrials.gov 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:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents