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Topical Steroid Treatment For Dry Eye

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Loteprednol Etabonate (FML)
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Inflammatory reaction, steroids

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meir Medical center
  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dry eye patients

Arm Description

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

Outcomes

Primary Outcome Measures

clinical improvement in dry eye measurements
tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment

Secondary Outcome Measures

symptomatic improvement
dry eye questionaire will be evaluated on each follow up

Full Information

First Posted
August 14, 2014
Last Updated
August 14, 2014
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02218827
Brief Title
Topical Steroid Treatment For Dry Eye
Official Title
Evaluation of Steroidal Treatment For Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Inflammatory reaction, steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dry eye patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate (FML)
Intervention Description
a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure
Primary Outcome Measure Information:
Title
clinical improvement in dry eye measurements
Description
tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment
Time Frame
two months
Secondary Outcome Measure Information:
Title
symptomatic improvement
Description
dry eye questionaire will be evaluated on each follow up
Time Frame
two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shay Ofir, Dr
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical center
City
Kfar Saba
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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Topical Steroid Treatment For Dry Eye

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