Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
Primary Purpose
Dry Eye Syndrome
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TJO-087
Cyclosporine ophthalmic solution 0.05%
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
Eligibility Criteria
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.
Sites / Locations
- Hyo Myung, KimRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TJO-087
Cyclosporine 0.05%
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05245604
First Posted
February 8, 2022
Last Updated
February 8, 2022
Sponsor
Taejoon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05245604
Brief Title
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taejoon Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TJO-087
Arm Type
Experimental
Arm Title
Cyclosporine 0.05%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TJO-087
Intervention Description
Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily
Intervention Type
Drug
Intervention Name(s)
Cyclosporine ophthalmic solution 0.05%
Intervention Description
Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day
Primary Outcome Measure Information:
Title
Change From Baseline in Non-anesthetic Schirmer Test at Week 32
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Time Frame
Baseline and Week 32
Secondary Outcome Measure Information:
Title
Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Time Frame
Baseline, Week 8, 16 and 24
Title
Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32
Description
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.
Time Frame
Baseline, Week 8, 16, 24 and 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sukyoung Kwon
Phone
82-2-799-0184
Email
skkwon@taejoon.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo Myung Kim, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hyo Myung, Kim
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo Myung Kim, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
We'll reach out to this number within 24 hrs