Study to Evaluate the Efficacy and Safety of CKD-352

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: CKD-352; Drug: Diquafosol Sodium 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 Type: Interventional
• Enrollment (Actual): 283
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Corneal Staining from Baseline and at Week 4	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Corneal Staining from Baseline and at Week 2	Baseline, Week 2
Changes in Conjunctival Staining from Baseline and at Week 2,4	Baseline, Week 2,4
Changes in Tear Break-up Time from Baseline and at Week 2, 4	Baseline, Week 2,4
Changes in Schirmer I Test from Baseline and at Week 2, 4	Baseline, Week 2,4
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4	Baseline, Week 2,4

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Jong Su Lee, M.D, Ph.D, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): May 7, 2021
• Study Completion (Actual): May 7, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye Disease; CKD-352
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: A100_01DED1924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No