Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

Taejoon Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Dry Eye Syndrome

Treatments: Drug: Cyclosporine ophthalmic solution 0.05%; Drug: TJO-087

Study type: Interventional

Funder types: Industry

Identifiers

NCT05245604

TJO-087-301

Details and patient eligibility

About

The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.

Enrollment: 182 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age 20 or over
• Patients with moderate to severe dry eye
• 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 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
• Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
• Intraocular pressure(IOP)> 25 mmHg
• Patient using or to use punctual plug within 1 months.
• Patients with contact lens.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

182 participants in 2 patient groups

TJO-087

Experimental group

Treatment:

Drug: TJO-087

Cyclosporine 0.05%

Active Comparator group

Treatment:

Drug: Cyclosporine ophthalmic solution 0.05%