NCT03888183

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	salt solution without 0.15% HA	received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
DRUG	preservative-free 0.15% HA	received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks

Timeline

• Start date: 2019-04-17
• Primary completion: 2020-01-22
• Completion: 2020-03-22
• First posted: 2019-03-25
• Last updated: 2019-09-19

Locations

1 site across 1 country: Taiwan