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

Taejoon Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Drug: TJO-018 (HA 0.15%); Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%; Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04127851

TJO-018

Details and patient eligibility

About

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.

Enrollment: 438 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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438 participants in 3 patient groups

Sodium Hyaluronate 0.15% mono-therapy

Experimental group

Description:

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

Treatment:

Drug: TJO-018 (HA 0.15%)

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

Active Comparator group

Description:

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.

Treatment:

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

HA 0.15% + CsA 0.05% (combination therapy)

Other group

Description:

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.

Treatment:

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