Overview

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

Status:
Unknown status
Trial end date:
2020-03-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chang Gung Memorial Hospital
Treatments:
Hyaluronic Acid
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
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.