Topical Steroid Treatment For Dry Eye
Evaluation of Steroidal Treatment For Dry Eye Disease
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 18, 2014
August 1, 2014
1 year
August 14, 2014
August 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
symptomatic improvement
two months
Study Arms (1)
dry eye patients
EXPERIMENTALLoteprednol Etabonate (FML) topical treatment 1 drop 4 times daily for 1 month then Loteprednol Etabonate (FML) 1 drop 2 times daily for 1 month
Interventions
a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure
Eligibility Criteria
You may qualify if:
- referral for ophthalmic examination due to dry eye symptoms
- ability to sign a concent form
You may not qualify if:
- former corneal, eyelid or lacrimal gland operations
- former orbital chemotherapy or irradiation treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Meir Medical center
Kfar Saba, Israel, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shay Ofir, Dr
Meir Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctir
Study Record Dates
First Submitted
August 14, 2014
First Posted
August 18, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 18, 2014
Record last verified: 2014-08