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OpenTrials
Completed

NCT Number: NCT01199510

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

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.

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Key information

Conditions

Dry Eye Cataract Surgery Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care

Other

Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively

Standard of care

Other

Post Cataract Surgery Standard of Care

Primary outcomes

  1. Ocular Comfort

    Time frame: 30 days

    Ocular comfort will be reported by the patient on a questionnaire

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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