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OpenTrials
Completed

NCT Number: NCT04127851

Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in 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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TJO-018 (HA 0.15%)

Drug

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

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

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

Primary outcomes

  1. Change From Baseline in Corneal Staining Score at Week 12

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 16, 2019
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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