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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127851
• Other study ID #: TJO-018
• Status: Completed
• Phase: Phase 4
• Start date: November 12, 2019
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2019
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: October 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• TJO-018 (HA 0.15%)
TJO-018 / one drop / 6 times daily in both eyes
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Taejoon Pharmaceutical Co., Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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