Topical Steroid Treatment For Dry Eye

August 14, 2014 updated by: shay ofir, Meir Medical Center

Evaluation of Steroidal Treatment For Dry Eye Disease

Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms. epidemiologic studies estimate that as many as 15% of the population over 60 years suffer from dry eye. the disease can be treated both topically through several drugs or through mechanical closure of the lacrimal drainage system. in the past decade a few studies demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the inflammatory process that occurs in it. this treatment rises goblet cell counts but in the meantime elevates the intra ocular pressure and elevates the risk for infections. steroids that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry eye disease. we with to subjectively and objectively evaluate an FDA approved topical steroidal drug in the treatment of dry eye.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

30 patients 21 year or older, from both sexes with no previous eyelid or corneal surgeries, refered to our outpatient clinics will be recruited and evaluated.

the initial examination will include schirmer1 test, Tear break up time test, a full ophthalmologic evaluation and a dry eye questionaire.

after signing a concent form patient will be treated with Loteprednol Etabonate four times a ady for a month, then a second examination will take place. after that and according to necessity patients will be treated with Loteprednol Etabonate two times daily for another month and return for a follow up examination. intraocular pressure will be evaluated in each follow up visit as well as dry eye symptoms, schirmer 1 test and tear break up time test.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • referral for ophthalmic examination due to dry eye symptoms
  • ability to sign a concent form

Exclusion Criteria:

  • former corneal, eyelid or lacrimal gland operations
  • former orbital chemotherapy or irradiation treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dry eye patients
Loteprednol Etabonate (FML) topical treatment 1 drop 4 times daily for 1 month then Loteprednol Etabonate (FML) 1 drop 2 times daily for 1 month
Drug: Loteprednol Etabonate (FML)
a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement in dry eye measurements
Time Frame: two months
tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment
two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptomatic improvement
Time Frame: two months
dry eye questionaire will be evaluated on each follow up
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Shay Ofir, Dr, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dry eye01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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