Status:
COMPLETED
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Patients must be at least 18 years of age
- Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01199510
Start Date
September 1 2010
End Date
June 1 2011
Last Update
November 18 2016
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