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Completed

NCT Number: NCT04548427

Study to Evaluate the Efficacy and Safety of CKD-352

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pusan National University Hospital

Pusan, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CKD-352

Drug

Eye Drop

Diquafosol Sodium 3%

Drug

Eye Drop

Primary outcomes

  1. Changes in Corneal Staining from Baseline and at Week 4

    Time frame: Baseline, Week 4

Secondary outcomes

  1. Changes in Corneal Staining from Baseline and at Week 2

    Time frame: Baseline, Week 2

  2. Changes in Conjunctival Staining from Baseline and at Week 2,4

    Time frame: Baseline, Week 2,4

  3. Changes in Tear Break-up Time from Baseline and at Week 2, 4

    Time frame: Baseline, Week 2,4

  4. Changes in Schirmer I Test from Baseline and at Week 2, 4

    Time frame: Baseline, Week 2,4

  5. Changes in Ocular Surface Disease Index from Baseline and at week 2, 4

    Time frame: Baseline, Week 2,4

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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