A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    100
  • sponsor
    Chong Kun Dang Pharmaceutical
Updated on 25 January 2021
hypertension
glaucoma
brimonidine tartrate ophthalmic solution
latanoprost
dorzolamide
pigmentary glaucoma
primary open angle glaucoma

Summary

The purpose of this study is to evaluate efficacy and safety of CKD-351

Description

Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients

Details
Condition EYE DISORDER, Ocular Hypertension, Glaucoma, Pigmentary glaucoma, Eye Disorders/Infections, Dry Eye Disease, Primary Open Angle Glaucoma, Eye Disorders/Infections (Pediatric), Eye Disease, Open Angle Glaucoma
Treatment CKD-351, Latanoprost+Dorzolmamide
Clinical Study IdentifierNCT04448223
SponsorChong Kun Dang Pharmaceutical
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

More than the age of 19 years old
Subjects who has primary open-angle glaucoma or ocular hypertension
Subjects who sign on an informed consent form willingly

Exclusion Criteria

Subjects with intraocular pressure 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
Subjects with a maximum corrected visual acuity 0.3 in the selected evaluation eye at Visit 1 or Visit 2
Subjects who were diagnosed as below
Aphakia
Intraocular lens
Acute or Chronic Closed-Angle Glaucoma
Secondary Glaucoma
Subjects with ocular inflammation or infection within the last 3 months
Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
Subjects who received topical or systemic steroids within the last 1 month
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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