Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery

Phase 4

Completed

• Conditions: Dry Eye; Cataract Surgery
• Interventions: Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care; Other: Standard of Care

• Registration Number: NCT01199510
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-13
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients must be at least 18 years of age
• Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care plus FID 112903	FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care	SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
Standard of Care only	Standard of Care	Post Cataract Standard of Care Regimen

Primary Outcome Measures

Name	Time	Method
Ocular Comfort	30 days	Ocular comfort will be reported by the patient on a questionnaire