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Topical Steroid Treatment For Dry Eye

Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dry Eye

Intervention: Loteprednol Etabonate (FML) (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Meir Medical Center

Official(s) and/or principal investigator(s):
Shay Ofir, Dr, Principal Investigator, Affiliation: Meir Medical Center

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.

Clinical Details

Official title: Evaluation of Steroidal Treatment For Dry Eye Disease

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: clinical improvement in dry eye measurements

Secondary outcome: symptomatic improvement

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.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Meir Medical center, Kfar Saba, Israel

Sheba Medical Center, Ramat Gan 52621, Israel

Additional Information

Israeli site for dry eye subjective evaluation

Starting date: September 2014
Last updated: August 14, 2014

Page last updated: August 23, 2015

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