Topical Steroid Treatment For Dry Eye

Clalit Health Services

Status: Unknown

Conditions: Dry Eye

Treatments: Drug: Loteprednol Etabonate (FML)

Study type: Interventional

Funder types: Other

Identifiers

NCT02218827

dry eye01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

dry eye patients

Experimental group

Description:

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

Treatment:

Drug: Loteprednol Etabonate (FML)