Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients

April 19, 2022 updated by: Taejoon Pharmaceutical Co., Ltd.

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

This is a prospective randomized study compared with active control and placebo arms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Hyung Keun, Lee
        • Contact:
          • Hyung Keun Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TJO-083 [Part 2]
1 drop 3 times a day
Drug: TJO-083
Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
PLACEBO_COMPARATOR: Placebo of TJO-083 [Part 2]
1 drop 6 times a day
Other: Placebo (vehicle)
1 drop 6 times a day
ACTIVE_COMPARATOR: Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]
1 drop 6 times a day
Drug: Diquafosol ophthalmic sodium solution 3%
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
Time Frame: Baseline and Day 2, 8

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]
Time Frame: Baseline and Week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
Time Frame: Baseline and Week 2, 4, 8 and 12
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 2, 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Hyung Keun Lee, MD, Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (ACTUAL)

April 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJO-083-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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