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

Phase 1

• Conditions: Dry Eye Syndromes
• Interventions: Other: Placebo (vehicle); Drug: TJO-083; Drug: Diquafosol ophthalmic sodium solution 3%

• Registration Number: NCT05346783
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-14
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-04-19
• Last Update Submitted: 2022-04-19
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo of TJO-083 [Part 2]	Placebo (vehicle)	1 drop 6 times a day
TJO-083 [Part 2]	TJO-083	1 drop 3 times a day
Diquas-s Ophthalmic solution 3% 0.4mL [Part 2]	Diquafosol ophthalmic sodium solution 3%	1 drop 6 times a day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hyung Keun, Lee; 🇰🇷 Seoul, Korea, Republic of