NCT02618304

Brief Summary

In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

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

April 20, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2016

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

November 18, 2015

Last Update Submit

January 8, 2019

Conditions

Meibomian Gland Dysfunction

Keywords

Meibomian gland dysfunctionLipiviewTear Lipid Layer

Outcome Measures

Primary Outcomes (2)

  • Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction

    1 and 2 months after treatment of meibomian gland dysfunction

  • Changes of ocular aberration after treatment of meibomian gland dysfunction

    ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)

    1 and 2 months after treatment of meibomian gland dysfunction

Secondary Outcomes (5)

  • Corneal erosion grade(oxford score)

    1 and 2 months after treatment of meibomian gland dysfunction

  • OSDI(ocular surface disease index)

    1 and 2 months after treatment of meibomian gland dysfunction

  • Meibomian gland abnormality

    1 and 2 months after treatment of meibomian gland dysfunction

  • Meibomian quality

    1 and 2 months after treatment of meibomian gland dysfunction

  • BUT(tear break-up time)

    1 and 2 months after treatment of meibomian gland dysfunction

Study Arms (1)

moderate to severe meibomian gland dysfunction

EXPERIMENTAL
Drug: Treatment of Meibomian gland dysfunction

Interventions

Treatment of Meibomian gland dysfunctionDRUG

artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.

moderate to severe meibomian gland dysfunction

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. age over 19 years old, with moderate to severe Meibomian gland dysfunction.

You may not qualify if:

  • patients with history of previous ocular or intraocular surgery
  • ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease
  • history of intolerance or hypersensitivity to any component of the study medications
  • wearing contact lenses during the study period, presence of current punctal occlusion
  • pregnancy, lactating women, and children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (4)

  • Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, Lemp MA, Nichols KK. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2065-85. doi: 10.1167/iovs.10-6997h. Print 2011 Mar. No abstract available.

    PMID: 21450920BACKGROUND

  • Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.

    PMID: 21450919BACKGROUND

  • 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

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 1, 2015

Study Start

April 20, 2015

Primary Completion

February 19, 2016

Study Completion

February 19, 2016

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

KR(1)