NCT00535054

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 9, 2010

Status Verified

February 1, 2010

Enrollment Period

2.4 years

First QC Date

September 23, 2007

Last Update Submit

February 7, 2010

Conditions

Dry Eye Syndrome

Keywords

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Schirmer Test, Lissamine Green Test and BUT.

    On enrollment and one month later.

Secondary Outcomes (1)

  • Questionaire

    One, three and four weeks after treatment commencement.

Study Arms (1)

Tears Again

EXPERIMENTAL

All subjects shall be treated with Tears Again.

Drug: Tears Again

Interventions

Tears AgainDRUG

Liposome Eye Spray

Tears Again

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Assaf Harofeh Medical Center,

Ẕerifin, Israel

Location

Related Publications (2)

  • 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.

    PMID: 15499517BACKGROUND

  • 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.

    PMID: 17199193BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • David Zadok, MD

    Department of Ophthalmology, Assaf Harofeh Medical Center,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 9, 2010

Record last verified: 2010-02

Locations

IL(1)