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

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 4

Conditions: Dry Eye

Treatments: Drug: preservative-free 0.15% HA; Drug: salt solution without 0.15% HA

Study type: Interventional

Funder types: Other

Identifiers

NCT03888183

201801577A3C601

Details and patient eligibility

About

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 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.

Enrollment: 334 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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334 participants in 2 patient groups, including a placebo group

salt solution without 0.15% HA

Placebo Comparator group

Treatment:

Drug: salt solution without 0.15% HA

preservative-free 0.15% HA

Active Comparator group

Treatment:

Drug: preservative-free 0.15% HA