Study to Evaluate the Efficacy and Safety of CKD-352

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Diquafosol Sodium 3%; Drug: CKD-352

Study type: Interventional

Funder types: Industry

Identifiers

NCT04548427

A100_01DED1924

Details and patient eligibility

About

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

Full 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

Enrollment: 283 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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283 participants in 2 patient groups

CKD-352

Experimental group

Treatment:

Drug: CKD-352

Diquafosol Sodium 3%

Active Comparator group

Treatment:

Drug: Diquafosol Sodium 3%