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

Sponsor

Taejoon Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05245604

Collaborator

(none)

182

Enrollment

Location

Arms

33.4

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: TJO-087 Drug: Cyclosporine ophthalmic solution 0.05%	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

182 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 19, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.