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

NCT06427031 | Completed Phase 3

• 1 other identifier: TJO-083-A03
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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

Dry Eye; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Corneal Staining at Week 4

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

  Baseline and Week 4

Secondary Outcomes (3)

• Change From Baseline in Corneal Staining at Week 8, 12

  Baseline and Week 8 and 12

• Change From Baseline in Conjunctival Staining at Week 4, 8 and 12

  Baseline and Week 4, 8 and 12

• Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12

  Baseline and Week 4, 8 and 12

Study Arms (2)

TJO-083

EXPERIMENTAL

TJO-083 : 1 drop 3 times a day

Drug: TJO-083

Diquas-s Ophthalmic solution 3% 0.4mL

ACTIVE COMPARATOR

1 drop 6 times a day

Drug: Diquafosol ophthalmic sodium solution 3%

Interventions

TJO-083 DRUG

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

TJO-083

Diquafosol ophthalmic sodium solution 3% DRUG

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Diquas-s Ophthalmic solution 3% 0.4mL

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taejoon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: July 14, 2023
• Primary Completion: May 22, 2024
• Study Completion: July 3, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)