NCT02645045

Brief Summary

In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant will underwent LLT measurement with a LipiView interferometer, tear meniscus height measurement using optical coherence tomography, tear film break-up time (TBUT) determination, corneal and conjunctival staining, Schirmer's test, examination of the lid margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

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

December 11, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

December 28, 2015

Last Update Submit

January 24, 2017

Conditions

Dry Eye Syndrome

Keywords

Dry eyeLipiviewTear Lipid Layermeibomian gland dysfunction

Outcome Measures

Primary Outcomes (1)

  • Tear Lipid Layer thickness measurement with a LipiView interferometer

    1 day

Secondary Outcomes (6)

  • tear meniscus height measurement using optical coherence tomography

    1 day

  • Corneal and conjunctival erosion grade(oxford score)

    1 day

  • tear film break-up time (TBUT)

    1 day

  • Schirmer's test (lacrimal secretion test)

    1 day

  • evaluation of the score of lid margins and meibomian glands

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Dry eye

Patients with dry eye syndrome

normal

Patients without dry eye

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

age over 19 years old, Patients with dry eye syndrome and normal subjects

You may qualify if:

  • \. age over 19 years old, Patients with dry eye syndrome and normal subjects

You may not qualify if:

  • patients less than 18 years of age and patients with histories of ocular surgery within 3 months; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease; and patients with the use of a punctal plug or topical ocular medications other than artificial tears.
  • Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, Seoul, 03722, South Korea

Location

Related Publications (4)

  • Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. doi: 10.1097/00006324-199009000-00010.

    PMID: 2234831BACKGROUND

  • Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.

    PMID: 21450915BACKGROUND

  • Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.

    PMID: 21450918BACKGROUND

  • McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. doi: 10.1016/s0014-4835(03)00203-3.

    PMID: 15106913BACKGROUND

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 1, 2016

Study Start

December 11, 2015

Primary Completion

February 10, 2016

Study Completion

February 10, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

no plan to share IPD

Locations

KR(1)