NCT03106532

Brief Summary

Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

March 6, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

March 30, 2017

Last Update Submit

October 25, 2018

Conditions

Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal IOP change

    Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks

    4 weeks

Secondary Outcomes (1)

  • The number of patient with adverse events

    28 days

Study Arms (3)

PHP-201 0.25% ophthalmic solution

EXPERIMENTAL

PHP-201 0.25% ophthalmic solution, TID

Drug: PHP-201 0.25% ophthalmic solution

PHP-201 0.5% ophthalmic solution

EXPERIMENTAL

PHP-201 0.5% ophthalmic solution, TID

Drug: PHP-201 0.5% ophthalmic solution

Placebo ophthalmic solution

PLACEBO COMPARATOR

Placebo ophthalmic solution, TID

Drug: Placebo ophthalmic solution

Interventions

PHP-201 0.25% ophthalmic solutionDRUG

3 drops daily, 28 days

Also known as: PHP-201
PHP-201 0.25% ophthalmic solution
PHP-201 0.5% ophthalmic solutionDRUG

3 drops daily, 28 days

Also known as: PHP-201
PHP-201 0.5% ophthalmic solution
Placebo ophthalmic solutionDRUG

3 drops daily, 28 days

Also known as: PHP-201
Placebo ophthalmic solution

Eligibility Criteria

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

You may qualify if:

  • years and older, female and male
  • IOP ≤21 mmHg
  • Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects
  • BCVA ≥+0.2

You may not qualify if:

  • Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc)
  • Subject who can't discontinue contact lenses
  • Subject who can't discontinue topical/systemic IOP lowering medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Interventions

sovesudilOphthalmic Solutions

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 10, 2017

Study Start

March 6, 2017

Primary Completion

May 2, 2018

Study Completion

May 2, 2018

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations

KR(1)