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NCT03364322 Clinical Trial

Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease

Dry Eye Syndrome Clinical Trial

Official title:
Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03364322
Other study ID # 2016-06-73
Secondary ID
Status Completed
Phase N/A
First received November 25, 2017
Last updated December 5, 2017
Start date June 1, 2016
Est. completion date June 30, 2017

Study information
Verified date December 2017
Source Hallym University Kangnam Sacred Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface disease is helpful.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 79 Years
Eligibility Inclusion Criteria:

- Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.

Exclusion Criteria:

- Subjects who are elderly (=80 years old) or have an autoimmune disease (e.g., Sjögren's syndrome and systemic lupus erythematosus) are excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Observation

Locations
Country Name City State
Korea, Republic of Kangnam Sacred Heart Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Tear osmolarity The tear film osmolarity (mOsm) is measured using TearLab (TearLab Co., San Diego, CA). 1 day
Other Eyelid hyperemia Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe 1 day
Other Conjunctivochalasis Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe fixed fold 1 day
Other visual analogue pain score visual analogue pain score indicates a higher level of discomfort. 0 to 10. 1 day
Other modification of SPEED score SPEED score using questionnaire indicates a higher level of discomfort. 1 day
Primary Ocular surface disease index The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability. 1 day
Secondary Tear break-up time 1 day
Secondary Schirmer tear secretion test Schirmer tear secretion test (mm) without anesthesia was performed using strip (Color Bar; Eagle vision. Memphis, TN) 1 day
Secondary Corneal fluorescence staining Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining. 1 day
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