Evaluate the Safety and Efficacy of TJO-087

Phase 2Active Not RecruitingNCT07810972

Taejoon Pharmaceutical Co., Ltd.90 enrolled

Overview

This study aims to evaluate the therapeutic efficacy and safety of investigational product compared with placebo in adult patients with dry eye disease. Patients will receive investigational product or placebo for 3 months, and the therapeutic effect will be assessed based on the change in corneal staining score from baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye Syndrome (DES)

Interventions

TJO-087DRUG

one drop in each eye, twice daily (1 drop of IP, 1 drop of placebo)

TJO-087DRUG

one drop in each eye, twice daily (2 dose of IP)

Vehicle (Placebo solution)DRUG

one drop in each eye, twice daily (2 dose of placebo)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged ≥20 years (male or female) * Patients with dry eye symptoms * Fluorescein corneal staining score(NEI scale) ≥4 * Schirmer test result (without anesthesia) ≤10 mm/5 min in * Tear film break-up time (TBUT) \<10 seconds Exclusion Criteria: * Presence or history of systemic or ocular disorder or condition that could affect the interpretation of study results * Intraocular pressure (IOP) \>21 mmHg * Planned use of contact lenses during the study period

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change From Baseline in Corneal Staining Score at 12 weeks

Change from Baseline in corneal staining using blue fluorescein staining procedure at 12 weeks.

Time frame: Week 12

Data from ClinicalTrials.gov

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