Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Refresh PM Ointment; Other: Lubricant eye drop FID 115958D

• Registration Number: NCT01076998
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-01
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Documented diagnosis of dry eye

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Exclusion Criteria

• Must not have worn contact lenses within 12 hours preceding enrollment
• Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Refresh PM Ointment	Refresh PM Ointment	Refresh PM Ointment
Lubricant eye drop	Lubricant eye drop FID 115958D	Lubricant eye drop

Primary Outcome Measures

Name	Time	Method
Three-minute visual blur profile	Through 3 minutes (post-instillation)
Overall Acceptability	Immediately upon instillation

Secondary Outcome Measures

Name	Time	Method
Drop Comfort Upon Instillation	Immediately upon installation