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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: salt solution without 0.15% HA
* Drug: preservative-free 0.15% HA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: salt solution without 0.15% HA<br> | Drug: salt solution without 0.15% HA<br>* received AIM Artificial Tears (4 to 8 times per day) with 12 weeks<br>* Other names: AIM Artificial Tears;|
| Active Comparator: preservative-free 0.15% HA<br> | Drug: preservative-free 0.15% HA<br>* received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks<br>* Other names: Per-Young Eye Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 8 weeks and 12 weeks | 
| 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). | 8 weeks and 12 weeks | 
| 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. | 8 weeks and 12 weeks | 
| 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. | 8 weeks and 12 weeks | 
| 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. | 8 weeks, 12 weeks | 
| 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. | 8 weeks, 12 weeks | 
| 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. | 8 weeks, 12 weeks | 
| 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. | 8 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyaluronic acid, salt solution, dry eye disease, ocular surface disease