Temperature on Evaporative Dry Eye

January 31, 2023 updated by: He Eye Hospital

Safety and Efficacy of Heated Artificial Tears Under Practical Conditions

Ocular surface temperature of a normal person is around 34.6 degree centigrade. After instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. Warm feeling will make blood vessels dilated and more blood will pass through to bring more blood flow out of our body to the heated area of the body and makes cells more permeable. Therefore, heating the ocular surface with heated eye mask after instilling artificial tears has the possibility to improve drug permeability on the ocular surface.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality, and reduced quality of life. 3% diquafosol (DQS) ophthalmic solution and heated eye mask (HEM) have been found to be beneficial in reducing signs and symptoms of dry eye. Warm compress therapy temperature of 40 °C to 45 °C have been typically advocated to melt the meibium causing obstruction at the orifices of the meibomian gland, eventually allowing increased lipid layer of the tear film. While in impact of heat on the ocular surface (OS) has not been extensively studied. Controlled and precise application of heat has the ability to create a cascade of events in the skin and thus aids in facilitating a faster movement of molecules into and across the skin. Possible mechanisms of enhancing drug permeation include on the ocular surface could be: (mechanisms may operate individually or concurrently):

  • increase in drug diffusivity in the vehicle and/or in the ocular surface
  • increase in partitioning and diffusion
  • alteration in the lipid structure
  • increased local blood flow Therefore, the purpose of this RCT is to assess the impact of instilling 3% DQS ophthalmic solution follow by HEM raising the OS temperature by 40 degrees centigrade for 10 minutes.

Study Type

Interventional

Enrollment (Anticipated)

45

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • The presence of at most one symptom including burning, foreign body sensation, itching or eye fatigue for 3 months
  • OSDI score ≥ 13 and TBUT <5 s or NIBUT < 10s
  • Able and willing to comply with the treatment/follow-up schedule

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 that should not put pressure
  • Active allergy or infection or inflammatory disease that may have prevented the subjects from completing the study at the ocular surface
  • Any structural change in lacrimal passage
  • Glaucoma
  • Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of ocular surface
  • Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, antidepressive, and antihistamine medications within 3 months

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DQS+HEM
Participants in the DQS+ group used DQS 1 drop 3 times/per day with heated eye mask for 2 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
Device: Heated eye mask
Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms
ACTIVE_COMPARATOR: DQS
Participants in the DQS group used DQS 1 drop 3 times/per day for 2 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
ACTIVE_COMPARATOR: HEM
Participants in the HEM group used heated eye mask 3 times/per day for 2 weeks
Device: Heated eye mask
Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms

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-7, and day-14

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-7, and day-14
Ocular Surface Disease Index (OSDI)
Time Frame: Day-0 (baseline), day-7, and day-14

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-7, and day-14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Time Frame: Day-0 (baseline), day-7, and day-14

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-7, and day-14
Meibomian gland function and secretion quality
Time Frame: Day-0 (baseline), day-7, and day-14

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-7, and day-14
Tear Film Lipid Layer Score (TFLL)
Time Frame: Day-0 (baseline), day-7, and day-14

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-7, and day-14
Tear meniscus height (TMH)
Time Frame: Day-0 (baseline), day-7, and day-14

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-7, and day-14
Conjunctival hyperemia (RS score)
Time Frame: Day-0 (baseline), day-7, and day-14

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-7, and day-14

Collaborators and Investigators

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

Sponsor

He Eye Hospital

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 (ANTICIPATED)

April 2, 2023

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDEDQS2023

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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