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Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days

NCT ID: NCT00946777

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-09-30

Brief Summary

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The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.

Detailed Description

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Conditions

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Dry Eye

Keywords

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Dry Eye Signs barrier function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systane® Ultra

Group Type EXPERIMENTAL

Systane® Ultra

Intervention Type OTHER

Systane® Ultra 1-2 drops, 4 times per day for 30 days

Interventions

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Systane® Ultra

Systane® Ultra 1-2 drops, 4 times per day for 30 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must have moderate corneal staining and exhibit a need to use artificial tears.

Exclusion Criteria

* Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
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

Countries

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United States

References

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Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10.2147/OPTH.S81355. eCollection 2015.

Reference Type RESULT
PMID: 26170605 (View on PubMed)

Other Identifiers

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SMA-09-04

Identifier Type: -

Identifier Source: org_study_id