Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
+ Standard of Care
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
Treatment Study
Summary
Study start date: September 1, 2010
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives