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

Sponsor

Taejoon Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05346783

Collaborator

(none)

Enrollment

Location

Arms

19.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective randomized study compared with active control and placebo arms.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: TJO-083 Other: Placebo (vehicle) Drug: Diquafosol ophthalmic sodium solution 3%	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients

Actual Study Start Date :

Oct 14, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TJO-083 [Part 2] 1 drop 3 times a day	Drug: TJO-083 Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
Placebo Comparator: Placebo of TJO-083 [Part 2] 1 drop 6 times a day	Other: Placebo (vehicle) 1 drop 6 times a day
Active Comparator: Diquas-s Ophthalmic solution 3% 0.4mL [Part 2] 1 drop 6 times a day	Drug: Diquafosol ophthalmic sodium solution 3% Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Arm

Intervention/Treatment

Experimental: TJO-083 [Part 2]

1 drop 3 times a day

Drug: TJO-083

Diquafosol ophthalmic sodium solution, 1 drop 3 times a day

Placebo Comparator: Placebo of TJO-083 [Part 2]

1 drop 6 times a day

Other: Placebo (vehicle)

1 drop 6 times a day

Active Comparator: Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]

1 drop 6 times a day

Drug: Diquafosol ophthalmic sodium solution 3%

Diquafosol ophthalmic sodium solution, 1 drop 6 times a day

Outcome Measures

Primary Outcome Measures

Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1] [Baseline and Day 2, 8]
Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below. Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia.
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2] [Baseline and Week 4]
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse)

Secondary Outcome Measures

Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2] [Baseline and Week 2, 4, 8 and 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.

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
Patient who have been diagnosed with dry eye syndrome at least 6 months ago
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 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
Intraocular pressure(IOP)> 21 mmHg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hyung Keun, Lee	Seoul		Korea, Republic of

Sponsors and Collaborators

Taejoon Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Hyung Keun Lee, MD, Gangnam Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taejoon Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05346783

Other Study ID Numbers:

TJO-083-121

First Posted:

Apr 26, 2022

Last Update Posted:

Apr 26, 2022

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Study Results

No Results Posted as of Apr 26, 2022