NCT03364322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 25, 2017

Last Update Submit

December 5, 2017

Conditions

Dry Eye SyndromeOcular Surface Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Tear break-up time

    1 day

  • Schirmer tear secretion test

    1 day

  • Corneal fluorescence staining

    1 day

Other Outcomes (5)

  • Tear osmolarity

    1 day

  • Eyelid hyperemia

    1 day

  • Conjunctivochalasis

    1 day

  • +2 more other outcomes

Study Arms (1)

Dry eye syndrome

Other: Observation

Interventions

ObservationOTHER

Observation

Dry eye syndrome

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Observation

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 6, 2017

Study Start

June 1, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

December 7, 2017

Record last verified: 2017-12

Locations

KR(1)