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

Phase 4

• Conditions: Dry Eye
• Interventions: Drug: salt solution without 0.15% HA; Drug: preservative-free 0.15% HA

• Registration Number: NCT03888183
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Study Start: 2019-04-17
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2020-01-22
• Study Completion: 2020-03-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 334

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
salt solution without 0.15% HA	salt solution without 0.15% HA	-
preservative-free 0.15% HA	preservative-free 0.15% HA	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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).
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.
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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan