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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04548427

Enrollment

283

Registered

2020-09-14

Start date

2020-09-22

Completion date

2021-05-07

Last updated

2021-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

Dry Eye Disease, CKD-352

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

Interventions

DRUGCKD-352

Eye Drop

DRUGDiquafosol Sodium 3%

Eye Drop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026