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OpenTrials
Active, not recruiting

NCT Number: NCT07810972

Evaluate the Safety and Efficacy of TJO-087

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dry Eye Syndrome (DES) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TJO-087

Drug

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

Vehicle (Placebo solution)

Drug

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

Primary outcomes

  1. Change From Baseline in Corneal Staining Score at 12 weeks

    Time frame: Week 12

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

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TJO-087

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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