Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients
1 other identifier
interventional
182
1 country
1
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 due to moderate or severe dry eye syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2020
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2020
CompletedFirst Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFebruary 18, 2022
February 1, 2022
2.1 years
February 8, 2022
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Non-anesthetic Schirmer Test at Week 32
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Baseline and Week 32
Secondary Outcomes (2)
Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24
Baseline, Week 8, 16 and 24
Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32
Baseline, Week 8, 16, 24 and 32
Study Arms (2)
TJO-087
EXPERIMENTALCyclosporine 0.05%
ACTIVE COMPARATORInterventions
Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hyo Myung, Kim
Seoul, South Korea
Related Publications (1)
Eom Y, Yoon KC, Kim HK, Song JS, Hyon JY, Kim HM. A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):27-35. doi: 10.1089/jop.2022.0119. Epub 2022 Nov 24.
PMID: 36450107DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo Myung Kim, MD, PhD
Korea University Anam Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 18, 2022
Study Start
June 19, 2020
Primary Completion
August 1, 2022
Study Completion
April 1, 2023
Last Updated
February 18, 2022
Record last verified: 2022-02