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OpenTrials
Completed

NCT Number: NCT00535054

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

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

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Assaf Harofeh Medical Center,

Ẕerifin, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tears Again

Drug

Liposome Eye Spray

Primary outcomes

  1. Schirmer Test, Lissamine Green Test and BUT.

    Time frame: On enrollment and one month later.

Secondary outcomes

  1. Questionaire

    Time frame: One, three and four weeks after treatment commencement.

Sponsors and collaborators

Lead sponsor

Trima, Israel Pharmaceutical Products

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2007
Registry last updated
Feb 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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