Topical Steroid Treatment For Dry Eye
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|ClinicalTrials.gov Identifier: NCT02218827|
Recruitment Status : Unknown
Verified August 2014 by shay ofir, Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Drug: Loteprednol Etabonate (FML)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Steroidal Treatment For Dry Eye Disease|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
Experimental: dry eye patients
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
Drug: Loteprednol Etabonate (FML)
a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure
- clinical improvement in dry eye measurements [ Time Frame: two months ]tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment
- symptomatic improvement [ Time Frame: two months ]dry eye questionaire will be evaluated on each follow up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218827
|Meir Medical center|
|Kfar Saba, Israel|
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||Shay Ofir, Dr||Meir Medical Center|