Topical Steroid Treatment For Dry Eye

Dry Eye Clinical Trial

Official title:

Evaluation of Steroidal Treatment For Dry Eye Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02218827
• Other study ID #: dry eye01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2014
• Last updated: August 14, 2014
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Loteprednol Etabonate (FML)
a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure

Locations

Country	Name	City	State
Israel	Meir Medical center	Kfar Saba
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical improvement in dry eye measurements	tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment	two months	No
Secondary	symptomatic improvement	dry eye questionaire will be evaluated on each follow up	two months	No