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.

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.