Back to resultsEfficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
Primary Purpose
Dry Eye, Cataract Surgery
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard of Care plus FID 112903
Standard of Care only
Arm Description
SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
Post Cataract Standard of Care Regimen
Outcomes
Primary Outcome Measures
Ocular Comfort
Ocular comfort will be reported by the patient on a questionnaire
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01199510
Brief Title
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Cataract Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care plus FID 112903
Arm Type
Experimental
Arm Description
SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
Arm Title
Standard of Care only
Arm Type
Active Comparator
Arm Description
Post Cataract Standard of Care Regimen
Intervention Type
Other
Intervention Name(s)
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Intervention Description
Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Post Cataract Surgery Standard of Care
Primary Outcome Measure Information:
Title
Ocular Comfort
Description
Ocular comfort will be reported by the patient on a questionnaire
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
12. IPD Sharing Statement
Citations:
Citation
http://www.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295
Results Reference
result
Learn more about this trial
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
We'll reach out to this number within 24 hrs