Topical Steroid Treatment For Dry Eye

Not Applicable

• Conditions: Dry Eye
• Interventions: Drug: Loteprednol Etabonate (FML)

• Registration Number: NCT02218827
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Last Update Submitted: 2014-08-14
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18
• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dry eye patients	Loteprednol Etabonate (FML)	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

Primary Outcome Measures

Name	Time	Method
clinical improvement in dry eye measurements	two months	tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment

Secondary Outcome Measures

Name	Time	Method
symptomatic improvement	two months	dry eye questionaire will be evaluated on each follow up

Trial Locations

Locations (2)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Meir Medical center; 🇮🇱 Kfar Saba, Israel