Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients

Study Overview
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Brief Summary
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In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug. Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.

Official Title
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A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients

Conditions
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Dry Eye, Dry Eye Syndromes

Intervention / Treatment
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* Drug: TJO-018 (HA 0.15%)
* Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)
* Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 20 or over Moderate to Severe Dry Eye Disease Patients Written informed consent to participate in the trial Exclusion Criteria: Any laser or ocular surgery within 2 months prior screening Use of contact lenses Any condition limiting patient's ability to participate in the trial

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
Interventional Model Description: A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Hyaluronate 0.15% mono-therapy<br>HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks | Drug: TJO-018 (HA 0.15%)<br>* TJO-018 / one drop / 6 times daily in both eyes<br>|
| Active Comparator: Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)<br>CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two   six times daily for 12 weeks. | Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)<br>* Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two six times daily in both eyes<br>|
| Other: HA 0.15% + CsA 0.05% (combination therapy)<br>HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks. | Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%<br>* TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Corneal Staining Score at Week 12 | After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. Scale: Oxford grading system that divides into six groups according to severity from 0 (absent) to 5 (severe). The higher scores mean a worse outcome. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Corneal Staining Score at Week 4 and Week 8 | After 4, 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. Scale: Oxford grading system that divides into six groups according to severity from 0 (absent) to 5 (severe). The higher scores mean a worse outcome. | Baseline, Week 4 and Week 8 |