Dry Eye SyndromesPhase 3NCT06388070
To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome
A Phase 3 study testing HA 0.3% and Hyalein Mini Eye Drops in people with Dry Eye Syndromes, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- HA 0.3% and Hyalein Mini Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2024to 21 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 19
- Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.
- Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes
- Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit
Who cannot join
- The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c>9%
- Wearing contact lenses within 72 hr of screening visit
- Pregnancy or Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome
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.
Read the detailed description
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- HA 0.3%, Hyalein Mini Eye Drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA 0.3%Drug
Instillation in each eye five to six times a day for 12 weeks
Hyalein Mini Eye DropsDrug
Also called Hyalein Mini 0.3%
Instillation in each eye five to six times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HUC3-053 | Experimental | Participants received "HUC3-053" in each eye five to six times a day for 12 weeks. Receives: Drug: HA 0.3% |
| Hyalein Mini Eye Drops | Active comparator | Participants received "Hyalein Mini Eye Drops" in each eye five to six times a day for 12 weeks. Receives: Drug: Hyalein Mini Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Corneal staining score
Change from Baseline in Corneal staining score at week 12
Measured: Week 12
Secondary outcomes (6)
Change from Baseline in Corneal staining score
Change from Baseline in Corneal staining score at week 4, 8
Measured: Week 4, 8
Change from Baseline in Conjunctival staining score
Change from Baseline in Conjunctival staining score at week 4, 8, 12
Measured: Week 4, 8, 12
Change from Baseline in Schirmer test
Change from Baseline in Schirmer test at week 4, 8, 12
Measured: 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
Measured: 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
Measured: 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
Measured: Week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start20 May 2024
- Primary completion14 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chul Young Choi, Principal investigator, Gangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388070
- Sponsor's protocol ID
- HUC3-053
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SJ, Kim JY, Kim DH, Lee JS, Kim EC, Shin YJ, Kim HK, Koh JW, Kim TI, Jung D, Choi CY. A Randomized Multicenter Study Comparing Low-Viscosity with Comparator 0.3% Hyaluronic Acid for the Treatment of Dry Eye Disease. Ophthalmol Ther. 2026 Jun;15(6):1927-1939. doi: 10.1007/s40123-026-01372-7. Epub 2026 Apr 17.
PubMed 41995979
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT06388070
- Acronym / sponsor ID
- HUC3-053
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUC3-053 | Experimental | Drug: HA 0.3%Participants received "HUC3-053" in each eye five to six times a day for 12 weeks. |
| Hyalein Mini Eye Drops | Active comparator | Drug: Hyalein Mini Eye DropsParticipants received "Hyalein Mini Eye Drops" in each eye five to six times a day for 12 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 19
- Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.
- Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes
- Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit
Key exclusion criteria (4 listed)
- The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c>9%
- Wearing contact lenses within 72 hr of screening visit
- Pregnancy or Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA 0.3%Instillation in each eye five to six times a day for 12 weeks | Drug | HUC3-053 |
| Hyalein Mini Eye DropsAlso: Hyalein Mini 0.3%Instillation in each eye five to six times a day for 12 weeks. | Drug | Hyalein Mini Eye Drops |
Primary outcome
Change from Baseline in Corneal staining score
Time frame: Week 12
Change from Baseline in Corneal staining score at week 12
6 secondary outcomes
Change from Baseline in Corneal staining score
Time frame: Week 4, 8
Change from Baseline in Conjunctival staining score
Time frame: Week 4, 8, 12
Change from Baseline in Schirmer test
Time frame: Week 4, 8, 12
Change from Baseline in Tear film break-up time
Time frame: Week 4, 8, 12
Change from Baseline in Ocular surface disease index
Time frame: Week 4, 8, 12
Change from Baseline in Eye Soreness after eye drop assessed by NRS
Time frame: Week 4, 8, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 41995979Kim SJ, Kim JY, Kim DH, Lee JS, Kim EC, Shin YJ, Kim HK, Koh JW, Kim TI, Jung D, Choi CY. A Randomized Multicenter Study Comparing Low-Viscosity with Comparator 0.3% Hyaluronic Acid for the Treatment of Dry Eye Disease. Ophthalmol Ther. 2026 Jun;15(6):1927-1939. doi: 10.1007/s40123-026-01372-7. Epub 2026 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chul Young Choi principal investigator
Gangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HA 0.3% and Hyalein Mini Eye Drops in people with Dry Eye Syndromes, run by Huons Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Corneal staining score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.