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NCT05245604 Clinical Trial

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

Dry Eye Syndrome Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05245604
Other study ID # TJO-087-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 19, 2020
Est. completion date April 2023

Study information
Verified date February 2022
Source Taejoon Pharmaceutical Co., Ltd.
Contact Sukyoung Kwon
Phone 82-2-799-0184
Email skkwon@taejoon.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 182
Est. completion date April 2023
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• TJO-087
Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily
• Cyclosporine ophthalmic solution 0.05%
Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

Locations
Country Name City State
Korea, Republic of Hyo Myung, Kim 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 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 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
Secondary 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
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