Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms

NCT ID: NCT00535054

Last Updated: 2010-02-09

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.

Detailed Description

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Conditions

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Dry Eye Syndrome

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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Tears Again

All subjects shall be treated with Tears Again.

Group Type EXPERIMENTAL

Tears Again

Intervention Type DRUG

Liposome Eye Spray

Interventions

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Tears Again

Liposome Eye Spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).
* Use artificial tears or any other treatment for these symptoms three or more times a day.

Exclusion Criteria

* Known hypersensitivity to Phenoxyethanol.
* Pregnant and lactating women.
* Receive other ophthalmic medication (except for eyelid hygiene preparations).
* Graft-versus-host disease patients.
* Participated during the last month in another clinical trial.
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trima, Israel Pharmaceutical Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Department of Ophthalmology, Assaf Harofeh Medical Center,Zerifin, Israel

Principal Investigators

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David Zadok, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Assaf Harofeh Medical Center,

Locations

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Department of Ophthalmology, Assaf Harofeh Medical Center,

Ẕerifin, , Israel

Site Status

Countries

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Israel

References

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Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. doi: 10.1055/s-2004-813715. German.

Reference Type BACKGROUND
PMID: 15499517 (View on PubMed)

Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W. [Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. doi: 10.1055/s-2006-927266. German.

Reference Type BACKGROUND
PMID: 17199193 (View on PubMed)

Other Identifiers

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06.11

Identifier Type: -

Identifier Source: org_study_id

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