Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
NCT ID: NCT01199510
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2010-09-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of Care plus FID 112903
SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
Standard of Care only
Post Cataract Standard of Care Regimen
Standard of Care
Post Cataract Surgery Standard of Care
Interventions
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FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
Standard of Care
Post Cataract Surgery Standard of Care
Eligibility Criteria
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Inclusion Criteria
* Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation
* 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.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Countries
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References
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http://www.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295
Other Identifiers
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SMA-09-05
Identifier Type: -
Identifier Source: org_study_id