Effect of ADDE on Tear Interferometry

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT05456061
Collaborator
(none)
152
1
4
42
3.6

Study Details

Study Description

Brief Summary

Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT.

Objective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry.

Design, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE.

Interventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).

Main Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.

Condition or Disease Intervention/Treatment Phase
  • Drug: 3% diquafosol eyedrops
  • Procedure: Silicone punctal plug insertion
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Group 1

No intervention

Active Comparator: Group 2

3% diquafosol eye drops 6 times / day

Drug: 3% diquafosol eyedrops
Diquas® (Santen, Osaka, Japan), six times per day.

Active Comparator: Group 3

Punctal plug insertion, lower eyelid

Procedure: Silicone punctal plug insertion
a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid

Active Comparator: Group 4

3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid

Drug: 3% diquafosol eyedrops
Diquas® (Santen, Osaka, Japan), six times per day.

Procedure: Silicone punctal plug insertion
a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid

Outcome Measures

Primary Outcome Measures

  1. Average LLT (LLTave) [Baseline and one month after 1 month of treatments]

    LLT was measured using the LipiView® II tear interferometer (Johnson & Johnson, New Brunswick, New Jersey, USA). The tear interferometer automatically records 20-second videos reflecting the TFLL on the inferior cornea. Simultaneously, the quantified LLT is measured over time in the interferometric color unit (ICU). One ICU corresponds to approximately 1 nm of LLT. The LipiView® II interferometer provides the average, maximum, and minimum LLT values. The average LLT (LLTave) reflects the LLT value at the stable phase of the TFLL spreading or equilibrium state.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.

  2. tear meniscus height (TMH) of <200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).

  3. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.

Exclusion Criteria:
  1. acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.

  2. a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.

  3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.

  4. Hypersecretory meibomian gland dysfunction (MGD)

  • When both eyes of a patient could be included, an eye with the lower TMH was selected.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital, Yonsei University College of Medicine Seoul Korea, Republic of 03722

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kyoung Yul Seo, Prof., Yonsei University
ClinicalTrials.gov Identifier:
NCT05456061
Other Study ID Numbers:
  • 4-2018-0634
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022