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

Taejoon Pharmaceutical Co., Ltd.182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

182

Conditions

Dry Eye Syndrome

Interventions

TJO-087DRUG

Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily

Cyclosporine ophthalmic solution 0.05%DRUG

Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hyo Myung, Kim

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change From Baseline in Non-anesthetic Schirmer Test at Week 32

The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Time frame: Baseline and Week 32

Secondary Outcomes

Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24

The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Time frame: Baseline, Week 8, 16 and 24

Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32

Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.

Time frame: Baseline, Week 8, 16, 24 and 32

Central Contacts

Sukyoung Kwon

CONTACT

82-2-799-0184 skkwon@taejoon.co.kr

Data from ClinicalTrials.gov

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