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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01199510
Collaborator
(none)
40
Enrollment
2
Arms
9
Duration (Months)

Study Details

Study Description

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
  • Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
  • Other: Standard of Care
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ocular Comfort [30 days]

    Ocular comfort will be reported by the patient on a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

No locations specified.

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01199510
Other Study ID Numbers:
  • SMA-09-05
First Posted:
Sep 13, 2010
Last Update Posted:
Nov 18, 2016
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:
Cataract
Ophthalmic Solutions
Lubricant Eye Drops

Study Results

No Results Posted as of Nov 18, 2016