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NCT05346783 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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