NCT03762369

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

November 14, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

November 14, 2018

Last Update Submit

November 30, 2018

Conditions

Primary Open-angle GlaucomaOcular Hypertension

Keywords

Primary Open-angle GlaucomaOcular HypertensionCKD-351

Outcome Measures

Primary Outcomes (1)

  • Change in mean intraocular pressure at 12 weeks compared to baseline

    Baseline, 12 weeks

Secondary Outcomes (2)

  • Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline

    Baseline, 4 weeks, 8 weeks

  • Changes in intraocular pressure by measurement time

    4 weeks, 8 weeks, 12 weeks

Other Outcomes (1)

  • Safety assessed by number of participants with treatment-related adverse events

    up to 24 weeks

Study Arms (3)

CKD-351

EXPERIMENTAL

Latanoprost+D930

Drug: CKD-351Drug: D930

Latanoprost

ACTIVE COMPARATOR
Drug: LatanoprostDrug: Placebo of CKD-351Drug: Placebo of D930

D930

ACTIVE COMPARATOR
Drug: D930Drug: Placebo of CKD-351

Interventions

CKD-351DRUG

twice a day

Also known as: Latanoprost+D930
CKD-351
LatanoprostDRUG

once a day

Latanoprost
D930DRUG

three times a day

CKD-351D930
Placebo of CKD-351DRUG

once a day

Latanoprost
Placebo of D930DRUG

three times a day

Latanoprost

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 who has primary Open-Angle Glaucoma or Ocular Hypertension
  • Subjects who sign on an informed consent form willingly

You may not qualify if:

  • Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
  • Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
  • 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
  • Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
  • Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
  • Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hosipital

Seoul, Jongno, South Korea

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • KiHo Park

    Seoul National University Hosipital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KiHo Park

CONTACT

82-10-3458-3172kihopark@snu.ac.kr

Study Design

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

Study Record Dates

First Submitted

November 14, 2018

First Posted

December 3, 2018

Study Start

December 7, 2018

Primary Completion

February 28, 2022

Study Completion

May 30, 2022

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)