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

Taejoon Pharmaceutical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: TJO-083; Other: Placebo (vehicle); Drug: Diquafosol ophthalmic sodium solution 3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT05346783

TJO-083-121

Details and patient eligibility

About

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

Enrollment: 98 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

98 participants in 3 patient groups, including a placebo group

TJO-083 [Part 2]

Experimental group

Description:

1 drop 3 times a day

Treatment:

Drug: TJO-083

Placebo of TJO-083 [Part 2]

Placebo Comparator group

Description:

1 drop 6 times a day

Treatment:

Other: Placebo (vehicle)

Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]

Active Comparator group

Description:

1 drop 6 times a day

Treatment:

Drug: Diquafosol ophthalmic sodium solution 3%