Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: ORB Ocular Emulsion; Other: SootheXP Emollient (Lubricant) Eye Drops

• Registration Number: NCT01066988
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-02
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-11
• Status Verified: 2012-02
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

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

Inclusion Criteria

• Patients (minimum age 18) meeting specific criteria for dry eye.

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Exclusion Criteria

• Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
• History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right Eye	ORB Ocular Emulsion	ORB Ocular Emulsion or SootheXP
Left Eye	SootheXP Emollient (Lubricant) Eye Drops	ORB Ocular Emulsion or SootheXP

Primary Outcome Measures

Name	Time	Method
Lipid layer thickness	Baseline through 120 minutes post instillation

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States