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

Primary Purpose

Dry Eye Syndromes

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TJO-083
Placebo (vehicle)
Diquafosol ophthalmic sodium solution 3%
Sponsored by
Taejoon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hyung Keun, LeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

TJO-083 [Part 2]

Placebo of TJO-083 [Part 2]

Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]

Arm Description

1 drop 3 times a day

1 drop 6 times a day

1 drop 6 times a day

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Full Information

First Posted
March 23, 2022
Last Updated
April 19, 2022
Sponsor
Taejoon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05346783
Brief Title
Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taejoon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TJO-083 [Part 2]
Arm Type
Experimental
Arm Description
1 drop 3 times a day
Arm Title
Placebo of TJO-083 [Part 2]
Arm Type
Placebo Comparator
Arm Description
1 drop 6 times a day
Arm Title
Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]
Arm Type
Active Comparator
Arm Description
1 drop 6 times a day
Intervention Type
Drug
Intervention Name(s)
TJO-083
Intervention Description
Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
Intervention Type
Other
Intervention Name(s)
Placebo (vehicle)
Intervention Description
1 drop 6 times a day
Intervention Type
Drug
Intervention Name(s)
Diquafosol ophthalmic sodium solution 3%
Intervention Description
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
Description
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.
Time Frame
Baseline and Day 2, 8
Title
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]
Description
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)
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Time Frame
Baseline and Week 2, 4, 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sukyoung Kwon
Phone
82-2-799-0184
Email
skkwon@taejoon.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung Keun Lee, MD
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hyung Keun, Lee
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung Keun Lee, MD

12. IPD Sharing Statement

Learn more about this trial

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

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