Topical Steroid Treatment For Dry Eye

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Steroidal Treatment For Dry Eye Disease

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Loteprednol Etabonate (FML)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dry eye patients<br>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)<br>* a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement in dry eye measurements | 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 | dry eye questionaire will be evaluated on each follow up | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Inflammatory reaction, steroids