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

Phase 4

Completed

• Conditions: Dry Eye; Dry Eye Syndromes
• Interventions: 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%

• Registration Number: NCT04127851
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-11-12
• Primary Completion: 2021-07-14
• Study Completion: 2021-10-14
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hyaluronate 0.15% mono-therapy	TJO-018 (HA 0.15%)	HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks
Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)	Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)	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.
HA 0.15% + CsA 0.05% (combination therapy)	TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Staining Score at Week 12	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Staining Score at Week 4 and Week 8	Baseline, 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.

Trial Locations

Locations (1)

Taejoon Pharmaceutical Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of