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Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

NCT ID: NCT01066988

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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

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Conditions

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Dry Eye

Keywords

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lipid layer thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Right Eye

ORB Ocular Emulsion or SootheXP

Group Type OTHER

ORB Ocular Emulsion

Intervention Type OTHER

lubricant eye drop

Left Eye

ORB Ocular Emulsion or SootheXP

Group Type OTHER

SootheXP Emollient (Lubricant) Eye Drops

Intervention Type OTHER

lubricant eye drop

Interventions

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ORB Ocular Emulsion

lubricant eye drop

Intervention Type OTHER

SootheXP Emollient (Lubricant) Eye Drops

lubricant eye drop

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.

Reference Type RESULT
PMID: 21750611 (View on PubMed)

Other Identifiers

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C-09-046

Identifier Type: -

Identifier Source: org_study_id