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.