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

A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients

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 Overview

• Status: Recruiting
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: TJO-087; Drug: Cyclosporine ophthalmic solution 0.05%

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hyo Myung, Kim
    • Contact: Hyo Myung Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TJO-087	Drug: TJO-087; Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily
Active Comparator: Cyclosporine 0.05%	Drug: Cyclosporine ophthalmic solution 0.05%; Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Week 8, 16, 24 and 32

Collaborators and Investigators

• Sponsor: Taejoon Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Hyo Myung Kim, MD, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: TJO-087-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No