Back to resultsEvaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
Primary Purpose
Normal Tension Glaucoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PHP-201 0.25% ophthalmic solution
PHP-201 0.5% ophthalmic solution
Placebo ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Normal Tension Glaucoma
Eligibility Criteria
Inclusion Criteria:
- 19 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
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
PHP-201 0.25% ophthalmic solution
PHP-201 0.5% ophthalmic solution
Placebo ophthalmic solution
Arm Description
PHP-201 0.25% ophthalmic solution, TID
PHP-201 0.5% ophthalmic solution, TID
Placebo ophthalmic solution, TID
Outcomes
Primary Outcome Measures
Mean diurnal IOP change
Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks
Secondary Outcome Measures
The number of patient with adverse events
The number of patient with adverse events including ocular adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03106532
Brief Title
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
Official Title
A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pH Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
Data collection (electronic case report forms), Data dictionary (MedDRA)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PHP-201 0.25% ophthalmic solution
Arm Type
Experimental
Arm Description
PHP-201 0.25% ophthalmic solution, TID
Arm Title
PHP-201 0.5% ophthalmic solution
Arm Type
Experimental
Arm Description
PHP-201 0.5% ophthalmic solution, TID
Arm Title
Placebo ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
Placebo ophthalmic solution, TID
Intervention Type
Drug
Intervention Name(s)
PHP-201 0.25% ophthalmic solution
Other Intervention Name(s)
PHP-201
Intervention Description
3 drops daily, 28 days
Intervention Type
Drug
Intervention Name(s)
PHP-201 0.5% ophthalmic solution
Other Intervention Name(s)
PHP-201
Intervention Description
3 drops daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo ophthalmic solution
Other Intervention Name(s)
PHP-201
Intervention Description
3 drops daily, 28 days
Primary Outcome Measure Information:
Title
Mean diurnal IOP change
Description
Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The number of patient with adverse events
Description
The number of patient with adverse events including ocular adverse events
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19 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
Exclusion Criteria:
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
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