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

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Ocular Hypertension; Primary Open-angle Glaucoma

Treatments: Drug: CKD-351; Drug: Placebo of CKD-351; Drug: D930; Drug: Placebo of D930; Drug: Latanoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT03762369

171GLC18006

Details and patient eligibility

About

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

Full description

Multi center, Randomized, Double-blind, Active controlled, Parallel design, Phase 3 trial to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients.

Enrollment: 384 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. More than the age of 19 years old
2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
3. Subjects who sign on an informed consent form willingly

Exclusion criteria

1. Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye

2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2

3. Subjects who were diagnosed as below with monocular or both eye

   • Acute or Chronic Closed-Angle Glaucoma
   • Secondary Glaucoma
   • Pseudoexfoliation Glaucoma
   • Neovascular Glaucoma
   • Aphakia
   • Phacocyst capsular torn intraocular lens

4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)

5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)

6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months

7. Subjects who have medical history following

   • Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
   • Subjects who received topical or systemic steroids within the last 1 months

8. Subjects who wore need to wear contact lenses during the study

9. Women who are nursing, pregnant or planning pregnancy during the study

10. Subjects with bronchial asthma or history

11. Subjects with severe renal impairment (creatinine clearance <30 ml / min at screening) or hyperchloremic acidosis

12. Subjects who have received any other investigational product within 1 month prior to randomization

13. Impossible subjects who participate in clinical trial by investigator's decision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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384 participants in 3 patient groups

CKD-351

Experimental group

Description:

Latanoprost+D930

Treatment:

Drug: D930

Drug: CKD-351

Latanoprost

Active Comparator group

Treatment:

Drug: Placebo of CKD-351

Drug: Placebo of CKD-351

Drug: Latanoprost

Drug: Placebo of D930

D930

Active Comparator group

Treatment:

Drug: D930

Drug: Placebo of CKD-351

Drug: Placebo of CKD-351