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
  Purpose

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

  Eligibility

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

No publications provided

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:
Cataract
Lens Diseases
Eye Diseases
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014