Evaluate the Safety and Efficacy of TJO-087

NCT07810972 | Active Not Recruiting Phase 2

• 1 other identifier: TJO-087-A02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndrome (DES)

Keywords

Dry eye syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Corneal Staining Score at 12 weeks

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

  Week 12

Study Arms (3)

Experimental group A

EXPERIMENTAL

Investigational product QD

Drug: TJO-087

Experimental group B

EXPERIMENTAL

Investigational product BID

Drug: TJO-087

Placebo

PLACEBO COMPARATOR

Placebo BID

Drug: Vehicle (Placebo solution)

Interventions

TJO-087 DRUG

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

Experimental group A

Vehicle (Placebo solution) DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taejoon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: April 6, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)