Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients
NCT ID: NCT06337981
Last Updated: 2024-04-29
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
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2021-11-22
2022-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test group 1
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
(AJU-S56 5% and placebo)
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
Test group 2
(AJU-S56 5%), 1drop/1times, 6times in a day
AJU-S56 5%
(AJU-S56 5%), 1drop/1times, 6times in a day
Comparator group
Placebo(Vehicle), 1drop/1times, 6times in a day
Placebo(Vehicle)
Placebo(Vehicle), 1drop/1times, 6times in a day
Interventions
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(AJU-S56 5% and placebo)
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
AJU-S56 5%
(AJU-S56 5%), 1drop/1times, 6times in a day
Placebo(Vehicle)
Placebo(Vehicle), 1drop/1times, 6times in a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to Severe Dry Eye Disease Patients
* Must meet all criteria listed below at least in one eye or both eyes. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs
* Written informed consent to participate in the trial
Exclusion Criteria
* Those who have medical history with intraocular surgery 12months before screening visit
* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
* Participation in other studies within 4weeks of screening visit
19 Years
ALL
No
Sponsors
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GL Pharm Tech Corporation
INDUSTRY
AJU Pharm Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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AJU Pharm Co., Ltd.
Seoul, , South Korea
Countries
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Other Identifiers
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21DE20901
Identifier Type: -
Identifier Source: org_study_id
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