Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease

• Sponsor: Hallym University Kangnam Sacred Heart Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03364322
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 15.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome; Ocular Surface Disease	Other: Observation

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Dry eye syndrome	Other: Observation; Observation

Outcome Measures

Primary Outcome Measures

1. Ocular surface disease index [1 day]

   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.

Secondary Outcome Measures

1. Tear break-up time [1 day]

2. Schirmer tear secretion test [1 day]

   Schirmer tear secretion test (mm) without anesthesia was performed using strip (Color Bar; Eagle vision. Memphis, TN)

3. Corneal fluorescence staining [1 day]

   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.

Other Outcome Measures

1. Tear osmolarity [1 day]

   The tear film osmolarity (mOsm) is measured using TearLab (TearLab Co., San Diego, CA).

2. Eyelid hyperemia [1 day]

   Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe

3. Conjunctivochalasis [1 day]

   Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe fixed fold

4. visual analogue pain score [1 day]

   visual analogue pain score indicates a higher level of discomfort. 0 to 10.

5. modification of SPEED score [1 day]

   SPEED score using questionnaire indicates a higher level of discomfort.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hallym University Kangnam Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Joo Shin, Principal Investigator, Hallym University Kangnam Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT03364322
• Other Study ID Numbers: 2016-06-73
• First Posted: Dec 6, 2017
• Last Update Posted: Dec 7, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome

Study Results

No Results Posted as of Dec 7, 2017