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

Taejoon Pharmaceutical Co., Ltd.438 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

438

Conditions

Dry Eye Dry Eye Syndromes

Interventions

TJO-018 (HA 0.15%)DRUG

TJO-018 / one drop / 6 times daily in both eyes

Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)DRUG

Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two\~six times daily in both eyes

TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%DRUG

TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 12

Secondary Outcomes

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.

Time frame: Baseline, Week 4 and Week 8

Data from ClinicalTrials.gov

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