A Phase 3 interventional study of HA 0.3% and Hyalein Mini Eye Drops in Dry Eye Syndromes, sponsored by Huons Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Huons Co., Ltd. (part of Huons Global) · Phase 3, Interventional, and Treatment
This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.
After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Eye Drops administered bilaterally five to six times a day for 12 weeks.
This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.
During a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. Randomization will then occur as 1:1 where patients will be assigned to receive HUC3-053 or Hyalein Mini Eye Drops given bilaterally five to six times a day. The treatment period is 12 weeks.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 297 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Huons Co., Ltd. is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received "HUC3-053" in each eye five to six times a day for 12 weeks.
Drug: HA 0.3%
Participants received "Hyalein Mini Eye Drops" in each eye five to six times a day for 12 weeks.
Drug: Hyalein Mini Eye Drops
Instillation in each eye five to six times a day for 12 weeks
Instillation in each eye five to six times a day for 12 weeks.
Also known as: Hyalein Mini 0.3%
Change from Baseline in Corneal staining score
Change from Baseline in Corneal staining score at week 12
Time frame: Week 12
Change from Baseline in Corneal staining score
Change from Baseline in Corneal staining score at week 4, 8
Time frame: Week 4, 8
Change from Baseline in Conjunctival staining score
Change from Baseline in Conjunctival staining score at week 4, 8, 12
Time frame: Week 4, 8, 12
Change from Baseline in Schirmer test
Change from Baseline in Schirmer test at week 4, 8, 12
Time frame: Week 4, 8, 12
Change from Baseline in Tear film break-up time
Change from Baseline in Tear film break-up time at week 4, 8, 12
Time frame: Week 4, 8, 12
Change from Baseline in Ocular surface disease index
Change from Baseline in Ocular surface disease index at week 4, 8, 12
Time frame: Week 4, 8, 12
Change from Baseline in Eye Soreness after eye drop assessed by NRS
Change from Baseline in Eye Soreness after eye drop assessed by NRS at week 4, 8, 12
Time frame: Week 4, 8, 12
Ran from May 2024 to primary completion in Mar 2025, 9 months.
Of 81 industry-sponsored phase 3 interventional studies under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's 9 months is close to that.
Counting every sponsor, half of 96 studies reached it within 10 months; a quarter within 7 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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