A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Lubricant Eye Drop; Other: Refresh Liquigel

• Registration Number: NCT01294956
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Documented diagnosis of dry eye
• NaFl Corneal staining sum score ≥ 3 in either eye
• Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

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Exclusion Criteria

• No contact lenses wear throughout the study period
• Must not have had punctal plugs inserted within 30 days preceding enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FID 115958D	Lubricant Eye Drop	Lubricant Eye Drop
Refresh Liquigel	Refresh Liquigel	Lubricant Eye Drop

Primary Outcome Measures

Name	Time	Method
Corneal Staining	Day 42