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

Taejoon Pharmaceutical Co., Ltd.1 site in 1 country271 target enrollmentJuly 14, 2023

ConditionsDry Eye Dry Eye Syndromes

InterventionsTJO-083 Diquafosol ophthalmic sodium solution 3%

DrugsTJO-083 Diquafosol ophthalmic sodium solution 3%

Overview

Phase: Phase 3
Intervention: TJO-083
Conditions: Dry Eye
Sponsor: Taejoon Pharmaceutical Co., Ltd.
Enrollment: 271
Locations: 1
Primary Endpoint: Change From Baseline in Corneal Staining at Week 4
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 14, 2023

End Date

July 3, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

TJO-083

TJO-083 : 1 drop 3 times a day

Intervention: TJO-083

Diquas-s Ophthalmic solution 3% 0.4mL

1 drop 6 times a day

Intervention: Diquafosol ophthalmic sodium solution 3%

Outcomes

Primary Outcomes

Change From Baseline in Corneal Staining at Week 4

Time Frame: Baseline and Week 4

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

Secondary Outcomes

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)