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Topical Steroid Treatment For Dry Eye

Evaluation of Steroidal Treatment For Dry Eye Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02218827
Enrollment
30
Registered
2014-08-18
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2014-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Dry Eye, Inflammatory reaction, steroids

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.

Interventions

DRUGLoteprednol Etabonate (FML)

a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical improvement in dry eye measurementstwo monthstear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment

Secondary

MeasureTime frameDescription
symptomatic improvementtwo monthsdry eye questionaire will be evaluated on each follow up

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026