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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346783
• Other study ID #: TJO-083-121
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 14, 2021
• Est. completion date: June 2023

Study information

• Verified date: October 2021
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: Sukyoung Kwon
• Phone: 82-2-799-0184
• Email: skkwon[@]taejoon.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Other:
• Placebo (vehicle)
1 drop 6 times a day

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

Locations

Country	Name	City	State
Korea, Republic of	Hyung Keun, Lee	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	Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]	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.	Baseline and Day 2, 8
Primary	Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]	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)	Baseline and Week 4
Secondary	Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]	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 2, 4, 8 and 12