Study to Evaluate the Efficacy and Safety of CKD-352

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-05-07

Brief Summary

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

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Detailed Description

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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

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CKD-352

Group Type EXPERIMENTAL

CKD-352

Intervention Type DRUG

Eye Drop

Diquafosol Sodium 3%

Group Type ACTIVE_COMPARATOR

Diquafosol Sodium 3%

Intervention Type DRUG

Eye Drop

Interventions

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CKD-352

Eye Drop

Intervention Type DRUG

Diquafosol Sodium 3%

Eye Drop

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No