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Oral Hyaluronic Acid Supplementation for the Treatment of Dry Eye Disease

Status Approved

First Submitted Date

2019/08/19
Registered Date

2019/08/21
Last Updated Date

2019/08/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004231
Unique Protocol ID	SCHBC 2019-08-16
Public/Brief Title	Oral Hyaluronic Acid Supplementation for the Treatment of Dry Eye Disease
Scientific Title	Oral Hyaluronic Acid Supplementation for the Treatment of Dry Eye Disease
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SCHBC 2019-08-16
Approval Date	2019-08-16
Institutional Review Board Name	Institutional Review Board of Soonchunhyang University Bucheon Hospital
Institutional Review Board Address	B2, Annex, 170, Jomaru-ro, Bucheon-si, Gyeonggi-do
Institutional Review Board Telephone	032-621-6360
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sun Young Jang
Title	Dr
Telephone	+82-32-621-6718
Affiliation	Soon Chun Hyang University Hospital Bucheon
Address	Gyeonggi-do Bucheon Jomaru-ro 170
Contact Person for Public Queries
Name	Sun Young Jang
Title	Dr
Telephone	+82-32-621-6718
Affiliation	Soon Chun Hyang University Hospital Bucheon
Address	Gyeonggi-do Bucheon Jomaru-ro 170
Contact Person for Updating Information
Name	Sun Young Jang
Title	Dr
Telephone	+82-32-621-6718
Affiliation	Soon Chun Hyang University Hospital Bucheon
Address	Gyeonggi-do Bucheon Jomaru-ro 170

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-08-19 Actual
Target Number of Participant	24
Primary Completion Date
Study Completion Date
Name of Study	Soon Chun Hyang University Hospital Bucheon
Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-08-19 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Soon Chun Hyang University Hospital Bucheon
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Soon Chun Hyang University Hospital Bucheon
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Background Dry eye disease (DED) is a common chronic ocular surface disease which is characterized by a loss of tear film homeostasis. It has multifactorial cause including tear film instability, hyperosmolarity, inflammation and neurosensory abnormalities and results in ocular discomfort and visual impairment. Hyaluronic acid (HA) is a macromolecular mucopolysaccharide that is widely distributed throughout connective, epithelial and neural tissues. HA has used in a tear supplements to enhance lubrication as a topical agent, and it has been proven to promote corneal epithelial wound healing. However, HA also can be supplemented in oral route. Public has ingested HA for the purpose of reducing joint pain in the knees of osteoarthritis and increasing skin hydration for dry skin. Studies have proven that oral HA has anti-inflammatory and skin moisturizing ability. However, to the best of our knowledge, there is no trial of oral HA supplementation for the treatment of DED. In this study, we assumed that anti-inflammatory and moisturizing effects of oral HA also might work in DED. We investigated the effect of oral HA supplementation for the treatment of DED. Purpose To evaluate the clinical efficacy of oral hyaluronic acid (HA) in patients with dry eye disease (DED).

Study Summary Information

Lay Summary

Background
Dry eye disease (DED) is a common chronic ocular surface disease which is characterized by a loss of tear film homeostasis. It has multifactorial cause including tear film instability, hyperosmolarity, inflammation and neurosensory abnormalities and results in ocular discomfort and visual impairment.

Hyaluronic acid (HA) is a macromolecular mucopolysaccharide that is widely distributed throughout connective, epithelial and neural tissues. HA has used in a tear supplements to enhance lubrication as a topical agent, and it has been proven to promote corneal epithelial wound healing. However, HA also can be supplemented in oral route. Public has ingested HA for the purpose of reducing joint pain in the knees of osteoarthritis and increasing skin hydration for dry skin. Studies have proven that oral HA has anti-inflammatory and skin moisturizing ability. However, to the best of our knowledge, there is no trial of oral HA supplementation for the treatment of DED. In this study, we assumed that anti-inflammatory and moisturizing effects of oral HA also might work in DED. We investigated the effect of oral HA supplementation for the treatment of DED.

Purpose
To evaluate the clinical efficacy of oral hyaluronic acid (HA) in patients with dry eye disease (DED).

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Retrospective
Target Number of Participant	24
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Dry eye patients
Cohort/ Group 1	Cohort/Group Description The inclusion criteria for this study were (1) > 18 years of age <65 years of age ; The patients who have taken oral hyaluronic acid. The patient who visited more than 3times before and after taking the oral hyaluronic acid.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Dry eye patients
Sampling Method	The inclusion criteria for this study were (1) > 18 years of age; (2) distance best-corrected visual acuity ≥ 20/40 Snellen equivalent in each eye; (3) IOP ≤ 21 mmHg in both eyes; (4) Ocular surface disease index (OSDI) score of ≥ 18 and < 65; (5) < 10 seconds of tear break up time (TBUT); (6) > 5 corneal spots of corneal fluorescein staining (CFS); [13] (7) ≤ 10mm/5min of Schirmer test
Condition(s)/Problem(s)	* (H00-H59)Diseases of the eye and adnexa (H04.11)Dry eye syndrome Dry eye
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~64Year
	Description Dry eye patients from the outpatient department Patients with a topical hyaluronic acid and supplemented with oral hyaluronic acid
Exclusion Criteria	less than 3 times visit during the study period imcomplete medical records regarding dry eye symptoms.
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	OSDI (ocular surface disease index)
Timepoint	1month
Secondary Outcome(s) 1
Outcome	schirmer test, tear film break up time, corenal fluorescein stain score
Timepoint	1month

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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