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
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

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