Study to Evaluate the Efficacy and Safety of CKD-352

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04548427
• Collaborator: (none)
• Enrollment: 283
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 37.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: CKD-352; Drug: Diquafosol Sodium 3%	Phase 3

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 283 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 22, 2020
• Actual Primary Completion Date: May 7, 2021
• Actual Study Completion Date: May 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CKD-352	Drug: CKD-352; Eye Drop
Active Comparator: Diquafosol Sodium 3%	Drug: Diquafosol Sodium 3%; Eye Drop

Outcome Measures

Primary Outcome Measures

1. Changes in Corneal Staining from Baseline and at Week 4 [Baseline, Week 4]

Secondary Outcome Measures

1. Changes in Corneal Staining from Baseline and at Week 2 [Baseline, Week 2]

2. Changes in Conjunctival Staining from Baseline and at Week 2,4 [Baseline, Week 2,4]

3. Changes in Tear Break-up Time from Baseline and at Week 2, 4 [Baseline, Week 2,4]

4. Changes in Schirmer I Test from Baseline and at Week 2, 4 [Baseline, Week 2,4]

5. Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 [Baseline, Week 2,4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Hospital	Pusan		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Study Chair: Jong Su Lee, M.D, Ph.D, Pusan National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04548427
• Other Study ID Numbers: A100_01DED1924
• First Posted: Sep 14, 2020
• Last Update Posted: Jun 1, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chong Kun Dang Pharmaceutical: Dry Eye Disease; CKD-352
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Jun 1, 2021