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

A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05346783

Enrollment

Registered

2022-04-26

Start date

2021-10-14

Completion date

2023-06-30

Last updated

2022-04-26

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

Conditions

Dry Eye Syndromes

Brief summary

This is a prospective randomized study compared with active control and placebo arms.

Interventions

DRUGTJO-083

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

OTHERPlacebo (vehicle)

1 drop 6 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

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, age 20 or over * Patient who have been diagnosed with dry eye syndrome at least 6 months ago * Screening both eyes, the corrected visual acuity is 0.2 or more * Written informed consent to participate in the trial

Exclusion criteria

* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) * Intraocular pressure(IOP)\> 21 mmHg

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]	Baseline and Day 2, 8	Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below. Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia.
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]	Baseline and Week 4	Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse)

Secondary

Measure	Time frame	Description
Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]	Baseline and Week 2, 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

Contacts

Primary ContactSukyoung Kwon

skkwon@taejoon.co.kr82-2-799-0184

Outcome results

None listed

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