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Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
salt solution without 0.15% HA
preservative-free 0.15% HA
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring hyaluronic acid, salt solution, dry eye disease, ocular surface disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects aged greater than or equal to 20 years (>= 20 years).
  • The symptom criterium of ocular surface disease index (OSDI) score > 13.

  • One of the two following examination criteria:

    1. Central tear meniscus height (TMHc) < 0.20 mm,
    2. Noninvasive tear-break time (NITBUT) < 6 s, for at least one eye.
  • Informed consent form (ICF) signed by the participant or a legal guardian.

Exclusion Criteria:

  • Male or female subjects aged less than 20 years (<20 years).
  • The symptom criterium of ocular surface disease index (OSDI) score < 13.
  • Central tear meniscus height (TMHc) > 0.20 mm and Noninvasive tear-break time (NITBUT) > 6 s for each eye.
  • Acute inflammatory eye diseases.
  • Receive ocular or eyelid surgeries before 6 months (except cataract surgery).
  • Allergy to HA
  • Pregnancy
  • Conditions judged by the investigator as unsuitable for this trial.

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

salt solution without 0.15% HA

preservative-free 0.15% HA

Arm Description

Outcomes

Primary Outcome Measures

Tear meniscus height
To compare the TMHc after blink of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.

Secondary Outcome Measures

Tear meniscus height
To compare the TMHc of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA .
Ocular surface disease index (OSDI) score
To compare the OSDI score of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. It was ranged from 0-100, in which higher score related to more severe symptom. It was subgroup into normal (0-12), mild (13-22), moderate(23-32), and severe (33-100).
Redness score
To compare the redness score of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. It was obtained by Keratograph® 5M, Oculus. The redness score, including total redness score, temporal and nasal bulbar scores, temporal and nasal limbal redness scores, showing the severity of dry eye. The higher redness area imply more severity of dry eye.
Lipid layer thickness
To compare the lipid layer thickness of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Tear film dynamics
To compare the tear film dynamics of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Non-invasive tear break-up time (NITBUT)
To compare the NITBUT of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Tear fern test
To compare the tear fern test of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Ocular surface staining
To compare the ocular surface staining of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. The ocular surface staining will be graded according to the Oxford Scheme. Fluorescein stain is applied on the ocular surface, and then corneal and conjunctival staining are evaluated under absorption filters. Staining will be labeled by punctate dots on a series of panels in order of increasing severity and score ranges from 0 to 5 for the treatment eye.

Full Information

First Posted
March 20, 2019
Last Updated
September 17, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03888183
Brief Title
Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease
Official Title
Short-term Supplemental Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease - A Randomized, Parallel-group, Double-blind, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
January 22, 2020 (Anticipated)
Study Completion Date
March 22, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a randomized, parallel-group, double-blind, controlled clinical trial to evaluate the effect of hyaluronic acid (HA) on dry eye disease.
Detailed Description
This trial is a randomized, parallel-group, double-blind, controlled clinical trial to compare intervention treatment (Per-Young Eye Drops: preservative-free 0.15% HA) against control treatment (AIM Artificial Tears: salt solution without 0.15% HA). All participants will be received Per-Young Eye Drops (4 to 8 times per day) or AIM Artificial Tears (4 to 8 times per day) with 12 weeks. Two drugs are identical in appearance and order of administration will be double-blind randomized. Primary endpoint: To compare the central tear meniscus height (TMHc) of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
hyaluronic acid, salt solution, dry eye disease, ocular surface disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
salt solution without 0.15% HA
Arm Type
Placebo Comparator
Arm Title
preservative-free 0.15% HA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
salt solution without 0.15% HA
Other Intervention Name(s)
AIM Artificial Tears
Intervention Description
received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
Intervention Type
Drug
Intervention Name(s)
preservative-free 0.15% HA
Other Intervention Name(s)
Per-Young Eye Drops
Intervention Description
received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
Primary Outcome Measure Information:
Title
Tear meniscus height
Description
To compare the TMHc after blink of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Tear meniscus height
Description
To compare the TMHc of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA .
Time Frame
8 weeks and 12 weeks
Title
Ocular surface disease index (OSDI) score
Description
To compare the OSDI score of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. It was ranged from 0-100, in which higher score related to more severe symptom. It was subgroup into normal (0-12), mild (13-22), moderate(23-32), and severe (33-100).
Time Frame
8 weeks and 12 weeks
Title
Redness score
Description
To compare the redness score of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. It was obtained by Keratograph® 5M, Oculus. The redness score, including total redness score, temporal and nasal bulbar scores, temporal and nasal limbal redness scores, showing the severity of dry eye. The higher redness area imply more severity of dry eye.
Time Frame
8 weeks and 12 weeks
Title
Lipid layer thickness
Description
To compare the lipid layer thickness of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Time Frame
8 weeks and 12 weeks
Title
Tear film dynamics
Description
To compare the tear film dynamics of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Time Frame
8 weeks, 12 weeks
Title
Non-invasive tear break-up time (NITBUT)
Description
To compare the NITBUT of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Time Frame
8 weeks, 12 weeks
Title
Tear fern test
Description
To compare the tear fern test of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.
Time Frame
8 weeks, 12 weeks
Title
Ocular surface staining
Description
To compare the ocular surface staining of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. The ocular surface staining will be graded according to the Oxford Scheme. Fluorescein stain is applied on the ocular surface, and then corneal and conjunctival staining are evaluated under absorption filters. Staining will be labeled by punctate dots on a series of panels in order of increasing severity and score ranges from 0 to 5 for the treatment eye.
Time Frame
8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged greater than or equal to 20 years (>= 20 years). The symptom criterium of ocular surface disease index (OSDI) score > 13. One of the two following examination criteria: Central tear meniscus height (TMHc) < 0.20 mm, Noninvasive tear-break time (NITBUT) < 6 s, for at least one eye. Informed consent form (ICF) signed by the participant or a legal guardian. Exclusion Criteria: Male or female subjects aged less than 20 years (<20 years). The symptom criterium of ocular surface disease index (OSDI) score < 13. Central tear meniscus height (TMHc) > 0.20 mm and Noninvasive tear-break time (NITBUT) > 6 s for each eye. Acute inflammatory eye diseases. Receive ocular or eyelid surgeries before 6 months (except cataract surgery). Allergy to HA Pregnancy Conditions judged by the investigator as unsuitable for this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ing-Chou Lai, MD
Phone
886-9-75056482
Email
lai1@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Tse Kuo, MD, PhD
Phone
886-9-75056495
Email
mingtse@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ing-Chou Lai, MD
Organizational Affiliation
Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ing-Chou Lai, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28736335
Citation
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.
Results Reference
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PubMed Identifier
22378109
Citation
Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.
Results Reference
background
PubMed Identifier
29240600
Citation
Cho WH, Lai IC, Fang PC, Chien CC, Tseng SL, Lai YH, Huang YT, Kuo MT. Meibomian Gland Performance in Glaucomatous Patients With Long-term Instillation of IOP-lowering Medications. J Glaucoma. 2018 Feb;27(2):176-183. doi: 10.1097/IJG.0000000000000841.
Results Reference
background
PubMed Identifier
29849166
Citation
Ho RW, Fang PC, Chao TL, Chien CC, Kuo MT. Increase lipid tear thickness after botulinum neurotoxin A injection in patients with blepharospasm and hemifacial spasm. Sci Rep. 2018 May 30;8(1):8367. doi: 10.1038/s41598-018-26750-5.
Results Reference
background
PubMed Identifier
29649988
Citation
Wang CY, Ho RW, Fang PC, Yu HJ, Chien CC, Hsiao CC, Kuo MT. The function and morphology of Meibomian glands in patients with thyroid eye disease: a preliminary study. BMC Ophthalmol. 2018 Apr 12;18(1):90. doi: 10.1186/s12886-018-0763-9.
Results Reference
background

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Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease

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