Back to resultsEffect of ADDE on Tear Interferometry
Primary Purpose
Tear, Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
3% diquafosol eyedrops
Silicone punctal plug insertion
Sponsored by
About this trial
This is an interventional diagnostic trial for Tear
Eligibility Criteria
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.
Sites / Locations
- Severance Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
No intervention
3% diquafosol eye drops 6 times / day
Punctal plug insertion, lower eyelid
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05456061
Brief Title
Effect of ADDE on Tear Interferometry
Official Title
Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tear, Dry Eye Syndromes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
3% diquafosol eye drops 6 times / day
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Punctal plug insertion, lower eyelid
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
Intervention Type
Drug
Intervention Name(s)
3% diquafosol eyedrops
Intervention Description
Diquas® (Santen, Osaka, Japan), six times per day.
Intervention Type
Procedure
Intervention Name(s)
Silicone punctal plug insertion
Intervention Description
a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid
Primary Outcome Measure Information:
Title
Average LLT (LLTave)
Description
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.
Time Frame
Baseline and one month after 1 month of treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of ADDE on Tear Interferometry
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