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

Phase 3

Completed

• Conditions: Dry Eye; Dry Eye Syndromes
• Interventions: Drug: TJO-083; Drug: Diquafosol ophthalmic sodium solution 3%

• Registration Number: NCT06427031
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-14
• Study First Submitted: 2024-05-19
• Study First Submitted QC: 2024-05-19
• Primary Completion: 2024-05-22
• Study First Posted: 2024-05-23
• Study Completion: 2024-07-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TJO-083	TJO-083	TJO-083 : 1 drop 3 times a day
Diquas-s Ophthalmic solution 3% 0.4mL	Diquafosol ophthalmic sodium solution 3%	1 drop 6 times a day

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Staining at Week 4	Baseline and Week 4	Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Staining at Week 8, 12	Baseline and Week 8 and 12	Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.
Change From Baseline in Conjunctival Staining at Week 4, 8 and 12	Baseline and Week 4, 8 and 12	Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at 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	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Trial Locations

Locations (1)

Taejoon Pharmaceutical Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of