Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

Dry Eye Clinical Trial

Official title:

A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427031
• Other study ID #: TJO-083-A03
• Status: Recruiting
• Phase: Phase 3
• Start date: July 14, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2023
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: Sukyoung Kwon, MPH., PhD
• Phone: +82-799-0175
• Email: skkwon[@]taejoon.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female, age 20 or over
• Has dry eye symptoms (minimum 3 months)
• Screening both eyes, the corrected visual acuity is 0.2 or more
• Written informed consent to participate in the trial

Exclusion Criteria:

• The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits.
• The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits.
• Intraocular pressure(IOP)> 21 mmHg
• Patients with contact lens

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• TJO-083
Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
• Diquafosol ophthalmic sodium solution 3%
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Locations

Country	Name	City	State
Korea, Republic of	Taejoon Pharmaceutical Co., Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Corneal Staining at Week 4	Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4.	Baseline and Week 4
Secondary	Change From Baseline in Corneal Staining at Week 8, 12	Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12.	Baseline and Week 8 and 12
Secondary	Change From Baseline in Conjunctival Staining at Week 4, 8 and 12	Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12	Baseline and Week 4, 8 and 12
Secondary	Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12	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 4, 8 and 12