Effect of ADDE on Tear Interferometry

NCT05456061 | Completed DMC

• 1 other identifier: 4-2018-0634
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Tear; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Group 1

NO INTERVENTION

No intervention

Group 2

ACTIVE COMPARATOR

3% diquafosol eye drops 6 times / day

Drug: 3% diquafosol eyedrops

Group 3

ACTIVE COMPARATOR

Punctal plug insertion, lower eyelid

Procedure: Silicone punctal plug insertion

Group 4

ACTIVE COMPARATOR

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

Drug: 3% diquafosol eyedrops; Procedure: Silicone punctal plug insertion

Interventions

3% diquafosol eyedrops DRUG

Diquas® (Santen, Osaka, Japan), six times per day.

Group 2; Group 4

Silicone punctal plug insertion PROCEDURE

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

Group 3; Group 4

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Lacerations; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Wounds and Injuries; Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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).

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: January 31, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)