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

NCT04127851 | Completed Phase 4

• 1 other identifier: TJO-018
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Corneal Staining Score at Week 4 and Week 8

  Baseline, Week 4 and Week 8

Study Arms (3)

Sodium Hyaluronate 0.15% mono-therapy

EXPERIMENTAL

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

Drug: TJO-018 (HA 0.15%)

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

ACTIVE COMPARATOR

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)

HA 0.15% + CsA 0.05% (combination therapy)

OTHER

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%

Interventions

TJO-018 (HA 0.15%) DRUG

TJO-018 / one drop / 6 times daily in both eyes

Sodium Hyaluronate 0.15% mono-therapy

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

Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two\~six times daily in both eyes

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

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

TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes

HA 0.15% + CsA 0.05% (combination therapy)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 20 or over
• Moderate to Severe Dry Eye Disease Patients
• Written informed consent to participate in the trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Taejoon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins; Standard of Care; MCC protocol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 12, 2019
• Primary Completion: July 14, 2021
• Study Completion: October 14, 2021
• Last Updated: June 8, 2022

Record last verified: 2019-10

Locations

KR (1)