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

Study Overview
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Brief Summary
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This is a prospective randomized study compared with active control and placebo arms.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: TJO-083
* Other: Placebo (vehicle)
* Drug: Diquafosol ophthalmic sodium solution 3%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |