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

Taejoon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Drug: TJO-083; Drug: Diquafosol ophthalmic sodium solution 3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06427031

TJO-083-A03

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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271 participants in 2 patient groups

TJO-083

Experimental group

Description:

TJO-083 : 1 drop 3 times a day

Treatment:

Drug: TJO-083

Diquas-s Ophthalmic solution 3% 0.4mL

Active Comparator group

Description:

1 drop 6 times a day

Treatment:

Drug: Diquafosol ophthalmic sodium solution 3%