NCT05720754

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

January 31, 2023

Last Update Submit

January 31, 2023

Conditions

Dry Eye

Keywords

dry eyeheated eye maskdiquafosoltear breakup timeocular surface disease index

Outcome Measures

Primary Outcomes (2)

  • Non-invasive tear break-up time (NIBUT)

    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)

    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 Outcomes (5)

  • Fluorescein and lissamine conjunctival and cornea staining (CFS)

    Day-0 (baseline), day-7, and day-14

  • Meibomian gland function and secretion quality

    Day-0 (baseline), day-7, and day-14

  • Tear Film Lipid Layer Score (TFLL)

    Day-0 (baseline), day-7, and day-14

  • Tear meniscus height (TMH)

    Day-0 (baseline), day-7, and day-14

  • Conjunctival hyperemia (RS score)

    Day-0 (baseline), day-7, and day-14

Study Arms (3)

DQS+HEM

EXPERIMENTAL

Participants in the DQS+ group used DQS 1 drop 3 times/per day with heated eye mask for 2 weeks

Drug: Diquafosol tetrasodiumDevice: Heated eye mask

DQS

ACTIVE COMPARATOR

Participants in the DQS group used DQS 1 drop 3 times/per day for 2 weeks

Drug: Diquafosol tetrasodium

HEM

ACTIVE COMPARATOR

Participants in the HEM group used heated eye mask 3 times/per day for 2 weeks

Device: Heated eye mask

Interventions

Diquafosol tetrasodiumDRUG

3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms

Also known as: Diquas
DQSDQS+HEM
Heated eye maskDEVICE

Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms

DQS+HEMHEM

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110034, China

Location

Related Publications (10)

  • Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5.

    PMID: 32836200RESULT

  • Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.

    PMID: 28736340RESULT

  • Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 2004 Apr;2(2):149-65. doi: 10.1016/s1542-0124(12)70150-7.

    PMID: 17216085RESULT

  • Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S20-S26. doi: 10.1016/j.ophtha.2017.05.031.

    PMID: 29055358RESULT

  • Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

    PMID: 28736335RESULT

  • Kulkarni AA, Trousdale MD, Stevenson D, Gukasyan HJ, Shiue MH, Kim KJ, Read RW, Lee VH. Nucleotide-induced restoration of conjunctival chloride and fluid secretion in adenovirus type 5-infected pigmented rabbit eyes. J Pharmacol Exp Ther. 2003 Jun;305(3):1206-11. doi: 10.1124/jpet.103.049221. Epub 2003 Mar 20.

    PMID: 12649304RESULT

  • Dota A, Sakamoto A, Nagano T, Murakami T, Matsugi T. Effect of Diquafosol Ophthalmic Solution on Airflow-Induced Ocular Surface Disorder in Diabetic Rats. Clin Ophthalmol. 2020 Apr 1;14:1019-1024. doi: 10.2147/OPTH.S242764. eCollection 2020.

    PMID: 32280196RESULT

  • Jumblatt JE, Jumblatt MM. Regulation of ocular mucin secretion by P2Y2 nucleotide receptors in rabbit and human conjunctiva. Exp Eye Res. 1998 Sep;67(3):341-6. doi: 10.1006/exer.1998.0520.

    PMID: 9778415RESULT

  • Tanioka H, Kuriki Y, Sakamoto A, Katsuta O, Kawazu K, Nakamura M. Expression of the P2Y(2) receptor on the rat ocular surface during a 1-year rearing period. Jpn J Ophthalmol. 2014 Nov;58(6):515-21. doi: 10.1007/s10384-014-0342-4. Epub 2014 Sep 2.

    PMID: 25179431RESULT

  • Cowlen MS, Zhang VZ, Warnock L, Moyer CF, Peterson WM, Yerxa BR. Localization of ocular P2Y2 receptor gene expression by in situ hybridization. Exp Eye Res. 2003 Jul;77(1):77-84. doi: 10.1016/s0014-4835(03)00068-x.

    PMID: 12823990RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Emmanuel Eric Pazo, MD, PhD

    He Eye Hospital, Shenyang, China

    STUDY CHAIR

Central Study Contacts

Emmanuel Eric Pazo, MD, PhD

CONTACT

0086-18612782131ericpazo@outlook.com

Chen Jiayan, MSc

CONTACT

0086-18304019060chenjiayan@hsyk.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the three groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

April 2, 2023

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The Steering Committee will write and submit the report for publication at the end of the study
Access Criteria
Use in clinical studies

Locations

CN(1)