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

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

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 Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: 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%

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Taejoon Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Hyaluronate 0.15% mono-therapy; HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks	Drug: TJO-018 (HA 0.15%); TJO-018 / one drop / 6 times daily in both eyes
Active Comparator: 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.	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
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taejoon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: TJO-018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No