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
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