Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a randomized, parallel-group, double-blind, controlled clinical trial to evaluate the effect of hyaluronic acid (HA) on dry eye disease.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| salt solution without 0.15% HA | Placebo Comparator |
| |
| preservative-free 0.15% HA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salt solution without 0.15% HA | Drug | received AIM Artificial Tears (4 to 8 times per day) with 12 weeks |
|
| 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 |
| 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 |
Not provided
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:
Informed consent form (ICF) signed by the participant or a legal guardian.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ing-Chou Lai, MD | Contact | 886-9-75056482 | lai1@cgmh.org.tw | |
| Ming-Tse Kuo, MD, PhD | Contact | 886-9-75056495 | mingtse@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ing-Chou Lai, MD | Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28736335 | Background | 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. | |
| 22378109 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| preservative-free 0.15% HA | Drug | received Per-Young Eye Drops (4 to 8 times per day) with 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).
| 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 |
| 29240600 | Background | 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. |
| 29849166 | Background | 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. |
| 29649988 | Background | 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. |