An Evaluation of the Safety and Efficacy of FID 114657

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: FID 114657; Other: Soothe XP Lubricant Eye Drops

• Registration Number: NCT01030237
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Primary Completion: 2010-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Documented diagnosis of dry eye
• NaFl Corneal Staining sum score ≥ 3 in either eye

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Exclusion Criteria

• Must not have worn contact lenses for 1 week preceding enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FID 114657	FID 114657	FID 114657
Soothe XP Lubricant Eye Drops	Soothe XP Lubricant Eye Drops	Soothe XP Lubricant Eye Drops

Primary Outcome Measures

Name	Time	Method
Tear Break-Up Time (TBUT)	measured at Days 0, 7, 14, 28 and 42
Corneal Staining	measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining	measured at Days 0, 7, 14, 28 and 42