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Effect of ADDE on Tear Interferometry

NCT05456061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2022-07-13

No results posted yet for this study

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.

Conditions

  • Tear
  • Dry Eye Syndromes

Interventions

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-08-01
Completion
2022-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456061 on ClinicalTrials.gov