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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions

Criteria

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.