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

Phase 3

• Conditions: Dry Eye Syndrome
• Interventions: Drug: TJO-087; Drug: Cyclosporine ophthalmic solution 0.05%

• Registration Number: NCT05245604
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-19
• Status Verified: 2022-02
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Primary Completion: 2022-08
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TJO-087	TJO-087	-
Cyclosporine 0.05%	Cyclosporine ophthalmic solution 0.05%	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Non-anesthetic Schirmer Test at Week 32	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32	Baseline, Week 8, 16, 24 and 32	Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.
Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24	Baseline, Week 8, 16 and 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.

Trial Locations

Locations (1)

Hyo Myung, Kim; 🇰🇷 Seoul, Korea, Republic of