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

Primary Purpose

Dry Eye, Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TJO-018 (HA 0.15%)
Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)
TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%
Sponsored by
Taejoon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Taejoon Pharmaceutical Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Sodium Hyaluronate 0.15% mono-therapy

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

HA 0.15% + CsA 0.05% (combination therapy)

Arm Description

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

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% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2019
Last Updated
June 6, 2022
Sponsor
Taejoon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04127851
Brief Title
Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taejoon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Hyaluronate 0.15% mono-therapy
Arm Type
Experimental
Arm Description
HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks
Arm Title
Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)
Arm Type
Active Comparator
Arm 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.
Arm Title
HA 0.15% + CsA 0.05% (combination therapy)
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
TJO-018 (HA 0.15%)
Intervention Description
TJO-018 / one drop / 6 times daily in both eyes
Intervention Type
Drug
Intervention Name(s)
Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)
Intervention Description
Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two~six times daily in both eyes
Intervention Type
Drug
Intervention Name(s)
TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%
Intervention Description
TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes
Primary Outcome Measure Information:
Title
Change From Baseline in Corneal Staining Score at Week 12
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Corneal Staining Score at Week 4 and Week 8
Description
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.
Time Frame
Baseline, Week 4 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Taejoon Pharmaceutical Co., Ltd.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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