## Protocol Section
### Identification Module
**NCT ID:** NCT06427031

**Brief Title:** Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

**Official Title:** A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

#### Organization Study ID Info
**ID:** TJO-083-A03
#### Organization
**Class:** INDUSTRY
**Full Name:** Taejoon Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-07-14

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Taejoon Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.

### Conditions Module

**Conditions:**

- Dry Eye

- Dry Eye Syndromes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 288

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** TJO-083 : 1 drop 3 times a day

**Intervention Names:**

- Drug: TJO-083

**Label:** TJO-083

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 1 drop 6 times a day

**Intervention Names:**

- Drug: Diquafosol ophthalmic sodium solution 3%

**Label:** Diquas-s Ophthalmic solution 3% 0.4mL

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TJO-083

**Description:** Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

**Name:** TJO-083

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Diquas-s Ophthalmic solution 3% 0.4mL

**Description:** Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

**Name:** Diquafosol ophthalmic sodium solution 3%

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.

**Measure:** Change From Baseline in Corneal Staining at Week 4

**Time Frame:** Baseline and Week 4

#### Secondary Outcomes

**Description:** Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.

**Measure:** Change From Baseline in Corneal Staining at Week 8, 12

**Time Frame:** Baseline and Week 8 and 12

**Description:** Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12

**Measure:** Change From Baseline in Conjunctival Staining at Week 4, 8 and 12

**Time Frame:** Baseline and Week 4, 8 and 12

**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.

**Measure:** Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12

**Time Frame:** Baseline and Week 4, 8 and 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female, age 20 or over
* Has dry eye symptoms (minimum 3 months)
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
* The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
* Intraocular pressure(IOP)\> 21 mmHg
* Patients with contact lens

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** skkwon@taejoon.co.kr

**Name:** Sukyoung Kwon, MPH., PhD

**Phone:** +82-799-0175

**Role:** CONTACT

**Contact 2:**

**Email:** SHADIK@yuhs.ac

**Name:** HyungKeun Lee, MD

**Phone:** +82-02-2019-3444

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** skkwon@taejoon.co.kr

- **Name:** Sukyoung Kwon

- **Phone:** 82)-2-799-0175

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Taejoon Pharmaceutical Co., Ltd.

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000007637

- Term: Keratoconjunctivitis

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000007634

- Term: Keratitis

- ID: D000003316

- Term: Corneal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: HIGH

- As Found: Dry Eye

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M10663

- Name: Keratoconjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6455

- Name: Conjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10660

- Name: Keratitis

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007638

- Term: Keratoconjunctivitis Sicca

- ID: D000005128

- Term: Eye Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
