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

Alcon

Status and phase

Completed

Phase 4

Conditions

Dry Eye

Cataract Surgery

Treatments

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

Other: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01199510

SMA-09-05

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.