Dry Eye
Conditions
Keywords
hyaluronic acid, salt solution, dry eye disease, ocular surface disease
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.
Interventions
DRUGsalt solution without 0.15% HA
received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
DRUGpreservative-free 0.15% HA
received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear meniscus height | 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Tear meniscus height | 8 weeks and 12 weeks | 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 | 8 weeks and 12 weeks | 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 | 8 weeks and 12 weeks | 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 | 8 weeks and 12 weeks | 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 | 8 weeks, 12 weeks | 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) | 8 weeks, 12 weeks | 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 | 8 weeks, 12 weeks | 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 | 8 weeks, 12 weeks | 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. |
Countries
Taiwan
Contacts
Primary ContactIng-Chou Lai, MD
Backup ContactMing-Tse Kuo, MD, PhD
Outcome results
None listed