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
Overview
- Phase
- Phase 4
- Intervention
- TJO-018 (HA 0.15%)
- Conditions
- Dry Eye
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Enrollment
- 438
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Corneal Staining Score at Week 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Arms & Interventions
Sodium Hyaluronate 0.15% mono-therapy
HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks
Intervention: TJO-018 (HA 0.15%)
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.
Intervention: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)
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.
Intervention: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%
Outcomes
Primary Outcomes
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
- Change From Baseline in Corneal Staining Score at Week 4 and Week 8(Baseline, Week 4 and Week 8)