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

Alcon Research0 sites40 target enrollmentSeptember 2010

ConditionsDry Eye Cataract Surgery

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Dry Eye
Sponsor: Alcon Research
Enrollment: 40
Primary Endpoint: Ocular Comfort
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

June 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility 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
•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.