Effect of ADDE on Tear Interferometry

Study Overview
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Brief Summary
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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.

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

Conditions
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Tear, Dry Eye Syndromes

Intervention / Treatment
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* Drug: 3% diquafosol eyedrops
* Procedure: Silicone punctal plug insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain. tear meniscus height (TMH) of <200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany). evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining. Exclusion Criteria: 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. 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. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded. Hypersecretory meibomian gland dysfunction (MGD) When both eyes of a patient could be included, an eye with the lower TMH was selected.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>No intervention | |
| Active Comparator: Group 2<br>3% diquafosol eye drops 6 times / day | Drug: 3% diquafosol eyedrops<br>* Diquas® (Santen, Osaka, Japan), six times per day.<br>|
| Active Comparator: Group 3<br>Punctal plug insertion, lower eyelid | Procedure: Silicone punctal plug insertion<br>* a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid<br>|
| Active Comparator: Group 4<br>3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid | Drug: 3% diquafosol eyedrops<br>* Diquas® (Santen, Osaka, Japan), six times per day.<br>Procedure: Silicone punctal plug insertion<br>* a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid<br>|

What is the study measuring?
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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 |