Study to Evaluate the Efficacy and Safety of CKD-352

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: CKD-352; Drug: Diquafosol Sodium 3%

• Registration Number: NCT04548427
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-14
• Study Start: 2020-09-22
• Status Verified: 2021-05
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-07
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-352	CKD-352	-
Diquafosol Sodium 3%	Diquafosol Sodium 3%	-

Primary Outcome Measures

Name	Time	Method
Changes in Corneal Staining from Baseline and at Week 4	Baseline, Week 4

Secondary Outcome Measures

Name	Time	Method
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4	Baseline, Week 2,4
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

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of