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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Tears Again

• Registration Number: NCT00535054
• Lead Sponsor: Trima, Israel Pharmaceutical Products

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-23
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-07
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tears Again	Tears Again	All subjects shall be treated with Tears Again.

Primary Outcome Measures

Name	Time	Method
Schirmer Test, Lissamine Green Test and BUT.	On enrollment and one month later.

Secondary Outcome Measures

Name	Time	Method
Questionaire	One, three and four weeks after treatment commencement.

Trial Locations

Locations (1)

Department of Ophthalmology, Assaf Harofeh Medical Center,; 🇮🇱 Zerifin, Israel