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Dry Eye DiseasePhase 3NCT05743764

HU007 in Patients with Dry Eye Syndrome

A Phase 3 study testing HU007, Restasis and Moisview Eye drop in people with Dry Eye Disease, run by Huons Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
HU007, Restasis and Moisview Eye drop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
1 siteSouth Korea
Study dates
23 Mar 2023to 14 Feb 2024
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
  • 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 in at least one of both eyes
  • Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit
  • Best corrected visual acuity of 0.2 or higher in both eyes
  • Those who voluntarily decided to participate and agreed in writing to comply with the precautions

Who cannot join

  • 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 prior to screening visit or during clinical trial
  • Pregnancy or Breastfeeding
  • Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes
  • Patient with autoimmune disease (e.g. sjogren's syndrome)
  • Patients with a history of corneal transplant or neurotrophic keratitis

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Gyeongsang National University Hospital

    Jinju, 52727

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

Conditions
Dry Eye Disease
Being tested
HU007, Restasis, Moisview Eye drop
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.

  • HU007Drug

    cyclosporine 0.02%, trehalose 3%

  • RestasisDrug

    cyclosporine 0.05%

  • Moisview Eye dropDrug

    trehalose 3%

Study groups in NCT05743764
Study groupRoleWhat they receive
HU007ExperimentalCyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Receives: Drug: HU007
RestasisActive comparatorCyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks
Receives: Drug: Restasis
MoisviewActive comparatortrehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Receives: Drug: Moisview Eye drop

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in corneal staining score

    Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline

    • Oxford grading: 0(Absent) to 5(Severe)

    Measured: 12weeks

Secondary outcomes (6)

  1. Change from baseline in corneal staining score

    Change in corneal staining score assessed on Oxford grading at 4, 8 weeks compared to baseline

    Measured: 4, 8weeks

  2. Change from baseline in conjuctival staining score

    Change in conjuctival staining score assessed on Oxford grading at 4, 8, 12 weeks compared to baseline

    Measured: 4, 8, 12weeks

  3. Change from baseline in strip meniscometry score

    Change in strip meniscometry score at 4, 8, 12 weeks compared to baseline

    Measured: 4, 8, 12weeks

  4. Change from baseline in TBUT score

    Change in TBUT score at 4, 8, 12 weeks compared to baseline

    Measured: 4, 8, 12weeks

  5. Change from baseline in SPEED dry eye questionnaire score

    Change in SPEED dry eye questionnaire score at 4, 8, 12 weeks compared to baseline

    Measured: 4, 8, 12weeks

  6. Time to achieve 100% clearance in corneal staining

    Time to achieve 100% clearance in corneal staining up to 12 weeks

    Measured: 12weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start23 Mar 2023
  3. Primary completion14 Feb 2024
  4. Study completion14 Feb 2024

Resources

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
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743764
Sponsor's protocol ID
HUC2-007_P3-2
Status last verified
Sep 2024
First submitted
14 Feb 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HU007, Restasis and Moisview Eye drop in people with Dry Eye Disease, 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 5 inclusion and 8 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 26 Sep 2024. 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: 12weeks). 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 NCT05743764.

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 26 Sep 2024.

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