Management of DE With IPL in Combination With DQS

July 22, 2023 updated by: He Eye Hospital

Management of Dry Eye With Intense Pulsed Light in Combination With Diquafosol

Intense pulsed light (IPL) has been reported to improve signs and symptoms of dry eye (DE). Additionally, meibomian gland secretion of lipids has been observed to improve through the use of IPL. Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells. Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function. The purpose of this prospective study was to evaluate and compare the effects of IPL (IPL group), DQS (DQS group) and IPL in combination with DQS (IPL+ group) in participants with persistent DE. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), tear meniscus height (TMH), corneoconjunctival staining score (CS), meibum gland (MG) function, conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaporative dry eye (EDE) has been reported to be the most prevalent form of dry eye disease (DED), which is primarily caused by meibomian gland hypofunction or meibomian gland dysfunction (MGD). MGD is defined as ''a chronic, diffuse anomaly of the meibomian glands, often characterized by terminal duct blockage and/or qualitative/quantitative alterations in glandular secretion'' by the International Workshop on MGD.These glands are modified sebaceous glands that release meibum directly onto the ocular surface. Signs and symptoms of EDE and MGD can be addressed by improving the quality and quantity of meibum secretion.

Intense pulsed light (IPL) is widely used to treat dermatological conditions, and its noncoherent polychromatic light source with wide wavelength range of 500-1200 nm has been reported to stimulate facial sebaceous glands. The photothermal effect of IPL is postulated to relieve inflammation by removing aberrant surface microvasculature and enhances meibomian gland function. Furthermore, an increase in fibroblast proliferation, collagen formation and local blood flow has been associated with the application of IPL on the skin. Several studies have documented the benefits of IPL in alleviating signs and symptoms of DED on the periocular skin.

Diquafosol ophthalmic solution (DQS) is a dinucleotide polyphosphate which a purinoceptor agonist, when administered to the ocular surface, it binds to P2Y2 receptors and stimulates mucin and tear secretion. The corneal epithelium, conjunctival epithelium, lacrimal gland ductal epithelium, meibomian gland sebaceous cells, and meibomian gland ductal cells all express the P2Y2 receptor. Subsequently, enhanced secretion of mucin and tear secretion due to DQS ophthalmic solution leads to stabilization of the tear film, minimizes tear evaporation, and reduces mechanical friction thereby protecting the corneal epithelium.

The purpose of this study is to assess the management of DE by combining IPL and DQS eye drops.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110034
        • He Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Consenting participants
  • Able and willing to comply with the treatment/follow-up schedule
  • Bilateral signs and symptoms of dry eye disease: (i) Ocular Surface Disease Index (OSDI) questionnaire ≥13, (ii) Non-invasive tear break-up (NITBUT) ≤ 5 seconds, (iii) conjunctival staining score (CS) ≥3 points. The presence of two or more criteria was used to establish a positive DE diagnosis based on the 2016 Asia Dry Eye Society criteria

Exclusion Criteria:

  • A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications.
  • Eyelids or intraocular tumors.
  • Active allergy or infection, or inflammatory disease may prevent the subjects from completing the study at the ocular surface.
  • Any structural changes in the lacrimal passage
  • Glaucoma
  • Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of the ocular surface.
  • Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, anti-depressive, and antihistamine medications, within three months.
  • Pregnancy or breastfeeding
  • Contact lenses wearers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPL+
Participants in the IPL+ group used DQS 1 drop 6 times/per day for four weeks along with 2 sessions of IPL, 2 weeks apart.
Device: Intense pulsed light
IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Other Names:
  • IPL
Drug: Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Other Names:
  • Diquas
Experimental: IPL
IPL treatment sessions were administered once at 2- weeks interval to all participants for 4 weeks.
Device: Intense pulsed light
IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Other Names:
  • IPL
Experimental: DQS
DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 4 weeks.
Drug: Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Other Names:
  • Diquas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear break-up time (NIBUT)
Time Frame: Day-0 (baseline), day-14 and day-28

Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined.
Day-0 (baseline), day-14 and day-28
Ocular Surface Disease Index (OSDI)
Time Frame: Day-0 (baseline), day-14 and day-28

OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome.

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined
Day-0 (baseline), day-14 and day-28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Time Frame: Day-0 (baseline), day-14 and day-28

Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface.

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined.
Day-0 (baseline), day-14 and day-28
Meibomian gland function and secretion quality
Time Frame: Day-0 (baseline), day-14 and day-28

Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum)

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined.
Day-0 (baseline), day-14 and day-28
Tear Film Lipid Layer Score (TFLL)
Time Frame: Day-0 (baseline), day-14 and day-28

Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed.

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined.
Day-0 (baseline), day-14 and day-28
Tear meniscus height (TMH)
Time Frame: Day-0 (baseline), day-14 and day-28

Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded.

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined.
Day-0 (baseline), day-14 and day-28
Conjunctival hyperemia (RS score)
Time Frame: Day-0 (baseline), day-14 and day-28

Conjunctival hyperemia (RS score) will be assessed by Keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 (normal) to 4.0 (severe).

  • Changes at day-14 and day-28 will be compare with baseline measurements.
  • Comparison between groups at baseline, day-14 and day-28 will also be examined.
Day-0 (baseline), day-14 and day-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Emmanuel Eric Pazo, MD, PhD, He Eye Hospital, Shenyang, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPLDQS2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.

IPD Sharing Time Frame

The Steering Committee will write and submit the report for publication at the end of the study

IPD Sharing Access Criteria

Use in clinical studies

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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