Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
328 participants
INTERVENTIONAL
2023-03-23
2024-02-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
NCT03461575
HU007 Eye Drops in Patients With Dry Eye Syndrome
NCT04384991
Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
NCT02917512
To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome
NCT06388070
Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis
NCT05733624
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HU007
Cyclosporine 0.02%, trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks
HU007
cyclosporine 0.02%, trehalose 3%
Restasis
Cyclosporine 0.05%
1 drop b.i.d at 12hr interval for 12 weeks
Restasis
cyclosporine 0.05%
Moisview
trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks
Moisview Eye drop
trehalose 3%
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HU007
cyclosporine 0.02%, trehalose 3%
Restasis
cyclosporine 0.05%
Moisview Eye drop
trehalose 3%
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huons Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jun young Hyun
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gyeongsang National University Hospital
Jinju, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUC2-007_P3-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.