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
PHASE1
32 participants
INTERVENTIONAL
2016-12-31
2018-04-01
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
NONE
Study Groups
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[A]→[A]+[B]
Period 1 : At each dosing of Treatment A eye drops is administered for 8days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days
[A]
One eye drop(about 40ul) / Day1 \~ Day8 / BID
[A]+[B](1)
One eye drop(about 40ul) / Day9 \~ Day100 / BID
[B]→[A]+[B]
Period 1 : At each dosing of Treatment B eye drops is administered for 92days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days
[B]
One eye drop(about 40ul) / Day1 \~ Day92 / BID
[A]+[B](2)
One eye drop(about 40ul) / Day93 \~ Day100 / BID
Interventions
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[A]
One eye drop(about 40ul) / Day1 \~ Day8 / BID
[B]
One eye drop(about 40ul) / Day1 \~ Day92 / BID
[A]+[B](1)
One eye drop(about 40ul) / Day9 \~ Day100 / BID
[A]+[B](2)
One eye drop(about 40ul) / Day93 \~ Day100 / BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
* Signed the informed consent form prior to study participation.
Exclusion Criteria
19 Years
50 Years
MALE
Yes
Sponsors
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Kukje Pharma
OTHER
Responsible Party
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Principal Investigators
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Kyung-sang Yu, Ph.d., M.B.A
Role: PRINCIPAL_INVESTIGATOR
Clinical Trial Center, Seoul National University Hospital
Locations
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Clinical Trial Center, Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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KJ-TFC-004
Identifier Type: -
Identifier Source: org_study_id
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