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Topical Steroid Treatment For Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
shay ofir, Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Loteprednol Etabonate (FML) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. symptomatic improvement [ Time Frame: two months ]
    dry eye questionaire will be evaluated on each follow up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02218827

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Meir Medical center
Kfar Saba, Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Meir Medical Center
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Principal Investigator: Shay Ofir, Dr Meir Medical Center
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Responsible Party: shay ofir, Medical Doctir, Meir Medical Center Identifier: NCT02218827    
Other Study ID Numbers: dry eye01
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by shay ofir, Meir Medical Center:
Dry Eye
Inflammatory reaction
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Loteprednol Etabonate
Anti-Allergic Agents