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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tears Again
Sponsored by
Trima, Israel Pharmaceutical Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Ophthalmology, Assaf Harofeh Medical Center,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tears Again

Arm Description

All subjects shall be treated with Tears Again.

Outcomes

Primary Outcome Measures

Schirmer Test, Lissamine Green Test and BUT.

Secondary Outcome Measures

Questionaire

Full Information

First Posted
September 23, 2007
Last Updated
February 7, 2010
Sponsor
Trima, Israel Pharmaceutical Products
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1. Study Identification

Unique Protocol Identification Number
NCT00535054
Brief Title
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
Official Title
An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Trima, Israel Pharmaceutical Products

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tears Again
Arm Type
Experimental
Arm Description
All subjects shall be treated with Tears Again.
Intervention Type
Drug
Intervention Name(s)
Tears Again
Intervention Description
Liposome Eye Spray
Primary Outcome Measure Information:
Title
Schirmer Test, Lissamine Green Test and BUT.
Time Frame
On enrollment and one month later.
Secondary Outcome Measure Information:
Title
Questionaire
Time Frame
One, three and four weeks after treatment commencement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zadok, MD
Organizational Affiliation
Department of Ophthalmology, Assaf Harofeh Medical Center,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Assaf Harofeh Medical Center,
City
Zerifin
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15499517
Citation
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.
Results Reference
background
PubMed Identifier
17199193
Citation
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.
Results Reference
background

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

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