Status:
UNKNOWN
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
Lead Sponsor:
Taejoon Pharmaceutical Co., Ltd.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production ...
Eligibility Criteria
Inclusion
- Male or female, age 20 or over
- Patients with moderate to severe dry eye
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Exclusion
- Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
- Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Intraocular pressure(IOP)\> 25 mmHg
- Patient using or to use punctual plug within 1 months.
- Patients with contact lens.
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05245604
Start Date
June 19 2020
End Date
April 1 2023
Last Update
February 18 2022
Active Locations (1)
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1
Hyo Myung, Kim
Seoul, South Korea