Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
1 other identifier
interventional
98
1 country
1
Brief Summary
This is a prospective randomized study compared with active control and placebo arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2021
CompletedFirst Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedApril 26, 2022
October 1, 2021
1.1 years
March 23, 2022
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below. Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia.
Baseline and Day 2, 8
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse)
Baseline and Week 4
Secondary Outcomes (1)
Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
Baseline and Week 2, 4, 8 and 12
Study Arms (3)
TJO-083 [Part 2]
EXPERIMENTAL1 drop 3 times a day
Placebo of TJO-083 [Part 2]
PLACEBO COMPARATOR1 drop 6 times a day
Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]
ACTIVE COMPARATOR1 drop 6 times a day
Interventions
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day
Eligibility Criteria
You may qualify if:
- Male or female, age 20 or over
- Patient who have been diagnosed with dry eye syndrome at least 6 months ago
- 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 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Intraocular pressure(IOP)\> 21 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hyung Keun, Lee
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyung Keun Lee, MD
Gangnam Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 26, 2022
Study Start
October 14, 2021
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
April 26, 2022
Record last verified: 2021-10