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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2021-10-14

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.

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Detailed Description

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Conditions

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Dry Eye Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sodium Hyaluronate 0.15% mono-therapy

HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks

Group Type EXPERIMENTAL

TJO-018 (HA 0.15%)

Intervention Type DRUG

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

Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

HA 0.15% + CsA 0.05% (combination therapy)

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.

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

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TJO-018 (HA 0.15%)

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No