Effect of ADDE on Tear Interferometry

Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Tear
• Intervention / Treatment: Drug: 3% diquafosol eyedrops; Procedure: Silicone punctal plug insertion

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average LLT (LLTave)	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.	Baseline and one month after 1 month of treatments

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: 4-2018-0634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No