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NCT04548427 Clinical Trial

Study to Evaluate the Efficacy and Safety of CKD-352

Dry Eye Disease Clinical Trial

Official title:
Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04548427
Other study ID # A100_01DED1924
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 22, 2020
Est. completion date May 7, 2021

Study information
Verified date May 2021
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease

Description:

Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease

Recruitment information / eligibility
Status Completed
Enrollment 283
Est. completion date May 7, 2021
Est. primary completion date May 7, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. More than the age of 19 years old 2. Subjects with dry eye symptoms for at least 3 month 3. Subjects who sign on an informed consent form willingly Exclusion Criteria: 1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora 2. Subjects who have clinically significant medical history of ocular disability 3. Subjects who have malignant tumor within 5 years 4. Subjects with known hypersensitivity to investigational product 5. Women who are nursing, pregnant or planning pregnancy during the study 6. Subjects who have received any other investigational product 7. Impossible subjects who participate in clinical trial by investigator's decision

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-352
Eye Drop
• Diquafosol Sodium 3%
Eye Drop

Locations
Country Name City State
Korea, Republic of Pusan National University Hospital Pusan

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Corneal Staining from Baseline and at Week 4 Baseline, Week 4
Secondary Changes in Corneal Staining from Baseline and at Week 2 Baseline, Week 2
Secondary Changes in Conjunctival Staining from Baseline and at Week 2,4 Baseline, Week 2,4
Secondary Changes in Tear Break-up Time from Baseline and at Week 2, 4 Baseline, Week 2,4
Secondary Changes in Schirmer I Test from Baseline and at Week 2, 4 Baseline, Week 2,4
Secondary Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 Baseline, Week 2,4
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