NCT04548427

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

September 10, 2020

Last Update Submit

May 27, 2021

Conditions

Dry Eye Disease

Keywords

Dry Eye DiseaseCKD-352

Outcome Measures

Primary Outcomes (1)

  • Changes in Corneal Staining from Baseline and at Week 4

    Baseline, Week 4

Secondary Outcomes (5)

  • 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

Study Arms (2)

CKD-352

EXPERIMENTAL
Drug: CKD-352

Diquafosol Sodium 3%

ACTIVE COMPARATOR
Drug: Diquafosol Sodium 3%

Interventions

CKD-352DRUG

Eye Drop

CKD-352
Diquafosol Sodium 3%DRUG

Eye Drop

Diquafosol Sodium 3%

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than the age of 19 years old
  • Subjects with dry eye symptoms for at least 3 month
  • Subjects who sign on an informed consent form willingly

You may not qualify if:

  • Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
  • Subjects who have clinically significant medical history of ocular disability
  • Subjects who have malignant tumor within 5 years
  • Subjects with known hypersensitivity to investigational product
  • Women who are nursing, pregnant or planning pregnancy during the study
  • Subjects who have received any other investigational product
  • Impossible subjects who participate in clinical trial by investigator's decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Pusan, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Jong Su Lee, M.D, Ph.D

    Pusan National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 14, 2020

Study Start

September 22, 2020

Primary Completion

May 7, 2021

Study Completion

May 7, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)