NCT01427816
Completed
Phase 2
A Randomized, Double Blind, Placebo Controlled, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
Overview
- Phase
- Phase 2
- Intervention
- KCT-0809
- Conditions
- Dry Eye Syndromes
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Corneal staining score
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Corneal and conjunctival damage
- •Insufficiency of lacrimal secretion
- •Ocular symptom
Exclusion Criteria
- •Severe ophthalmic disorder
- •Punctual plugs or surgery for occlusion of the lacrimal puncta
Arms & Interventions
KCT-0809 ophthalmic solution, low dose
Intervention: KCT-0809
KCT-0809 ophthalmic solution, high dose
Intervention: KCT-0809
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Corneal staining score
Time Frame: 6 weeks
Secondary Outcomes
- Conjunctival staining score(6 weeks)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Phase 2 Study of KLS-0611 in Patients With Dry Eye SyndromesDry Eye SyndromesNCT00721656Kissei Pharmaceutical Co., Ltd.80
Completed
Phase 3
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeNCT02503189Kissei Pharmaceutical Co., Ltd.
Completed
Phase 2
Safety and Efficacy of TOP1630 for Dry Eye SyndromeDry Eye SyndromeNCT03088605ORA, Inc.69
Terminated
Phase 3
An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeNCT02503176Kissei Pharmaceutical Co., Ltd.
Completed
Phase 2
[KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye SyndromeDry Eye SyndromesNCT05017844Kukje Pharma222