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Diquafosol vs Hyaluronic Acid for Diabetic Dry Eye

Primary Purpose

Diabetic Eye Problems

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3% Diquafosol tetrasodium
0.1% hyaluronate
Sponsored by
He Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Eye Problems focused on measuring Dry eye, Diquafosol, Hyaluronate, Diabetic dry eye

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years Clinical diagnosed and confirmed with type 2 diabetes for one year or more Able and willing to comply with the treatment/follow-up schedule Bilateral signs and symptoms of dry eye disease Exclusion Criteria: Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease Patients using topical medication(s) for the treatment of ocular disorders such as glaucoma or allergic conjunctivitis were excluded from the study. Previous ocular surgery or trauma 1-month history of blepharal and periorbital skin disease or allergies Severe dry eyes with corneal epithelial defect Limbic keratitis Pterygium Corneal neovascularization Glaucoma Breastfeeding Rheumatic immune systemic diseases Herpes zoster infection Pregnant women Allergic to fluorescein Contact lens wearers

Sites / Locations

  • He Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DQS group

HA group

Arm Description

Participants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 8 weeks.

Participants in HA group will be administered one drop of 0.1% Sodium hyaluronate artificial tears (preservative free) six times per day for 8 weeks

Outcomes

Primary Outcome Measures

Non-invasive tear break-up time
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.

Secondary Outcome Measures

Conjunctival hyperemia (RS score)
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 to 4.0. 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.
Quality of meibum grade
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.
Expressibility of meibum grade
Meibum expressibility will be assessed under a slit-lamp: Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands. 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.
Conjunctivocorneal epithelial staining grade
Conjunctivocorneal epithelial staining will be assessed under a slit-lamp: Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac. The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (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.
Tear Film Lipid Layer
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). 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.
OSDI Score
Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points 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.
MMP-9 detection
Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology.
Tear meniscus height (TMH)
Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer
Corneal Sensitivity Score
Corneal Sensitivity Score measured with Cochet-Bonnet esthesiometer (in mm filament length)
Corneal nerves and immune/inflammatory cells change
HRT III RCM, (Heidelberg Engineering GmbH, Dossenheim, Germany) will be used to record corneal nerves and immune/inflammatory cells change.

Full Information

First Posted
December 5, 2022
Last Updated
October 7, 2023
Sponsor
He Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05682547
Brief Title
Diquafosol vs Hyaluronic Acid for Diabetic Dry Eye
Official Title
A Single Center, Randomized, Controlled Trial Comparing the Clinical Efficacy of 3% Diquafosol Tetrasodium and 0.1 % Hyaluronic Acid 0.1% in Diabetic Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
He Eye Hospital

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
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. While it has been observed that 0.1 percent hyaluronate (HA) in artificial tears promotes corneal re-epithelium and improves corneal healing.This prospective, open label pilot study will include 60 eyes of 30 diabetic patients diagnosed with DED and will be randomly assigned to either DQS (n=30 eyes) or ATD group (n=30 eyes). Participants in the DQS group will receive 3% Diquafosol ophthalmic solution, while HA group will receive 0.1% Sodium hyaluronate artificial tears. The dosage for both drugs will be one drop, six times per day for 4 weeks. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), meibum gland (MG), conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.
Detailed Description
Type 2 diabetes mellitus (T2DM) is a prevalent chronic metabolic illness that causes relative insulin insufficiency in target organs owing to pancreatic β-cell dysfunction and insulin resistance [1]. Shift to sedentary lifestyle, ageing population and obesity has significantly contributed to the global rise in the prevalence of T2DM [2]. In 2019 the prevalence of diabetes was documented to be 9.3% (463 million people) and in 2030 it is estimated to rise to 10.2% (578 million) and T2DM accounts for approximately 90% of all diabetic occurrence[3]. Negative alterations to the tear film, corneal epithelium, corneal endothelium, and corneal nerves have been observed in 47-64% of patients with diabetes[4] [5]. Ocular surface manifestation of signs and symptoms secondary to DM has been termed as diabetic keratopathy (DK). DK has been documented to increase central corneal thickness[6], decrease in endothelial cell density[7], leads of superficial punctate keratitis[8], delay and impede wound repair[9], and decrease in corneal sensitivity due to neuropathy[10]. Additionally, DM patients have also been noted to have compromised tear quantity and quality[11][12] due to conjunctival goblet cell loss as documented on cytologic analysis [13]. Goblet cells secrete mucin, which stabilizes the tear film, minimizes tear evaporation, and reduces mechanical friction. Goblet cell loss in animal models suggests that it disrupts the ocular surface's immune tolerance [14] and increased expression of inflammatory cytokines in the conjunctiva[15]. 0.1% hyaluronate (HA) used in artificial tears have been reported to promote corneal re-epithelium and improve corneal healing[16]. Additionally, HA has been reported to decrease the rate of tear evaporation and enhance the stability of tear film [17]. Diquafosol tetrasodium 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[18-20]. The corneal epithelium, conjunctival epithelium, lacrimal gland ductal epithelium, meibomian gland sebaceous cells, and meibomian gland ductal cells all express the P2Y2 receptor. [21,22]. Subsequently, enhanced secretion of mucin and tear secretion due to Diquafosol tetrasodium ophthalmic solution (DQS) stabilize the tear film, minimizes tear evaporation, and reduces mechanical friction thereby protecting the corneal epithelium [23]. Various reports have concluded that that 3% DQS is effective in the treatment of dry eye disease [24-26] and Current [19] findings suggest that DQS improves corneal epithelial damage in T2DM rat model. However, the effect of DQS on the tear film of T2DM humans has not been previously assessed. Therefore, the purpose s to assess subjective and objective diabetic dry eye findings after using 3% DQS or 0.1% HA topical eye drops.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Eye Problems
Keywords
Dry eye, Diquafosol, Hyaluronate, Diabetic dry eye

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised control trial.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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 two groups.
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DQS group
Arm Type
Experimental
Arm Description
Participants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 8 weeks.
Arm Title
HA group
Arm Type
Active Comparator
Arm Description
Participants in HA group will be administered one drop of 0.1% Sodium hyaluronate artificial tears (preservative free) six times per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
3% Diquafosol tetrasodium
Other Intervention Name(s)
Diquas
Intervention Description
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in diabetic dry eye symptoms
Intervention Type
Drug
Intervention Name(s)
0.1% hyaluronate
Other Intervention Name(s)
Artificial tears
Intervention Description
0.1% hyaluronate eye drops will be used to assess its usefulness in diabetic dry eye symptoms and compared to 3% Diquafosol tetrasodium eye drops.
Primary Outcome Measure Information:
Title
Non-invasive tear break-up time
Description
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.
Time Frame
Day-0 (baseline), day-14 and day-28
Secondary Outcome Measure Information:
Title
Conjunctival hyperemia (RS score)
Description
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 to 4.0. 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.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Quality of meibum grade
Description
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.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Expressibility of meibum grade
Description
Meibum expressibility will be assessed under a slit-lamp: Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands. 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.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Conjunctivocorneal epithelial staining grade
Description
Conjunctivocorneal epithelial staining will be assessed under a slit-lamp: Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac. The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (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.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Tear Film Lipid Layer
Description
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). 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.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
OSDI Score
Description
Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points 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.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
MMP-9 detection
Description
Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology.
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Tear meniscus height (TMH)
Description
Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Corneal Sensitivity Score
Description
Corneal Sensitivity Score measured with Cochet-Bonnet esthesiometer (in mm filament length)
Time Frame
Day-0 (baseline), day-14 and day-28
Title
Corneal nerves and immune/inflammatory cells change
Description
HRT III RCM, (Heidelberg Engineering GmbH, Dossenheim, Germany) will be used to record corneal nerves and immune/inflammatory cells change.
Time Frame
Day-0 (baseline), week-4, and week-8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Clinical diagnosed and confirmed with type 2 diabetes for one year or more Able and willing to comply with the treatment/follow-up schedule Bilateral signs and symptoms of dry eye disease Exclusion Criteria: Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease Patients using topical medication(s) for the treatment of ocular disorders such as glaucoma or allergic conjunctivitis were excluded from the study. Previous ocular surgery or trauma 1-month history of blepharal and periorbital skin disease or allergies Severe dry eyes with corneal epithelial defect Limbic keratitis Pterygium Corneal neovascularization Glaucoma Breastfeeding Rheumatic immune systemic diseases Herpes zoster infection Pregnant women Allergic to fluorescein Contact lens wearers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Eric E Pazo, PhD
Phone
0086-18612782131
Email
ericpazo@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayan Chen, MSc
Phone
0086-13840298177
Email
jiangyixuan@hsyk.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Eric Pazo
Organizational Affiliation
He Eye Hospital, Shenyang, China
Official's Role
Study Chair
Facility Information:
Facility Name
He Eye Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li, M.D., Ph.D.
Phone
0086-15104083505
Email
robin_lijun@sina.com
First Name & Middle Initial & Last Name & Degree
Emmanuel Eric Pazo, M.D., Ph.D.
Phone
0086-18612782131
Email
ericpazo@outlook.com
First Name & Middle Initial & Last Name & Degree
Guanghao Qin, M.D.
First Name & Middle Initial & Last Name & Degree
Liangzhe Li, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Diquafosol vs Hyaluronic Acid for Diabetic Dry Eye

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