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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06427031

Enrollment

271

Registered

2024-05-23

Start date

2023-07-14

Completion date

2024-07-03

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Dry Eye Syndromes

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.

Interventions

DRUGTJO-083

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

DRUGDiquafosol ophthalmic sodium solution 3%

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026