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
Overview
- Phase
- Phase 4
- Intervention
- salt solution without 0.15% HA
- Conditions
- Dry Eye
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 334
- Locations
- 1
- Primary Endpoint
- Tear meniscus height
- Last Updated
- 6 years ago
Overview
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.
Investigators
Ing-Chou Lai, MD
Principal Investigator
Chang Gung Memorial Hospital
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 \>
- •One of the two following examination criteria:
- •Central tear meniscus height (TMHc) \< 0.20 mm,
- •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 \<
- •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.
Arms & Interventions
salt solution without 0.15% HA
Intervention: salt solution without 0.15% HA
preservative-free 0.15% HA
Intervention: preservative-free 0.15% HA
Outcomes
Primary Outcomes
Tear meniscus height
Time Frame: 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 Outcomes
- Redness score(8 weeks and 12 weeks)
- Non-invasive tear break-up time (NITBUT)(8 weeks, 12 weeks)
- Tear fern test(8 weeks, 12 weeks)
- Tear film dynamics(8 weeks, 12 weeks)
- Tear meniscus height(8 weeks and 12 weeks)
- Ocular surface disease index (OSDI) score(8 weeks and 12 weeks)
- Lipid layer thickness(8 weeks and 12 weeks)
- Ocular surface staining(8 weeks, 12 weeks)