Topical Steroid Treatment For Dry Eye

NCT ID: NCT02218827

Last Updated: 2014-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Loteprednol Etabonate (FML)

Intervention Type: DRUG

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

Interventions

Loteprednol Etabonate (FML)

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

shay ofir

Medical Doctir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shay Ofir, Dr

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical center

Kfar Saba, Israel, Israel

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Related Links

http://www.dryeye.co.il/evaluate

Israeli site for dry eye subjective evaluation

Other Identifiers

dry eye01

Identifier Type: -

Identifier Source: org_study_id