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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Drug: TJO-083; Drug: Diquafosol ophthalmic sodium solution 3%

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Taejoon Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TJO-083; TJO-083 : 1 drop 3 times a day	Drug: TJO-083; Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
Active Comparator: Diquas-s Ophthalmic solution 3% 0.4mL; 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Corneal Staining at Week 8, 12	Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.	Baseline and Week 8 and 12
Change From Baseline in Conjunctival Staining at Week 4, 8 and 12	Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure 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	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 4, 8 and 12

Collaborators and Investigators

• Sponsor: Taejoon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: TJO-083-A03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No