Clinical trial NCT03888183: Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Keywords: hyaluronic acid
salt solution
dry eye disease
ocular surface disease
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 334
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Tear meniscus height
timeFrame: 4 weeks
Secondary outcomes:
measure: Tear meniscus height
timeFrame: 8 weeks and 12 weeks
measure: Ocular surface disease index (OSDI) score
timeFrame: 8 weeks and 12 weeks
measure: Redness score
timeFrame: 8 weeks and 12 weeks
measure: Lipid layer thickness
timeFrame: 8 weeks and 12 weeks
measure: Tear film dynamics
timeFrame: 8 weeks, 12 weeks
measure: Non-invasive tear break-up time (NITBUT)
timeFrame: 8 weeks, 12 weeks
measure: Tear fern test
timeFrame: 8 weeks, 12 weeks
measure: Ocular surface staining
timeFrame: 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
name: Ing-Chou Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.