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

Overview

This trial is a randomized, parallel-group, double-blind, controlled clinical trial to evaluate the effect of hyaluronic acid (HA) on dry eye disease.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 22, 2020

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

  • Drug: salt solution without 0.15% HA
    • received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
  • Drug: preservative-free 0.15% HA
    • received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks

Arms, Groups and Cohorts

  • Placebo Comparator: salt solution without 0.15% HA
  • Active Comparator: preservative-free 0.15% HA

Clinical Trial Outcome Measures

Primary Measures

  • Tear meniscus height
    • Time Frame: 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 Measures

  • Tear meniscus height
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ing-Chou Lai, MD, Principal Investigator – Chang Gung Memorial Hospital
  • Overall Official(s)
    • Ing-Chou Lai, MD, Principal Investigator, Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
  • Overall Contact(s)
    • Ing-Chou Lai, MD, 886-9-75056482, lai1@cgmh.org.tw

References

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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.

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.

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.

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.

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