- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03106532
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
October 25, 2018 updated by: pH Pharma
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
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
Study Overview
Status
Completed
Conditions
Detailed Description
Data collection (electronic case report forms), Data dictionary (MedDRA)
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PHP-201 0.25% ophthalmic solution
PHP-201 0.25% ophthalmic solution, TID
|
3 drops daily, 28 days
Other Names:
|
EXPERIMENTAL: PHP-201 0.5% ophthalmic solution
PHP-201 0.5% ophthalmic solution, TID
|
3 drops daily, 28 days
Other Names:
|
PLACEBO_COMPARATOR: Placebo ophthalmic solution
Placebo ophthalmic solution, TID
|
3 drops daily, 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean diurnal IOP change
Time Frame: 4 weeks
|
Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of patient with adverse events
Time Frame: 28 days
|
The number of patient with adverse events including ocular adverse events
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 6, 2017
Primary Completion (ACTUAL)
May 2, 2018
Study Completion (ACTUAL)
May 2, 2018
Study Registration Dates
First Submitted
March 30, 2017
First Submitted That Met QC Criteria
April 7, 2017
First Posted (ACTUAL)
April 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHP-201-S203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Normal Tension Glaucoma
-
Qlaris Bio, Inc.CompletedNormal Tension Glaucoma (NTG)United States
-
University of North Carolina, Chapel HillSensimed AGCompletedNormal-Tension GlaucomaUnited States
-
Qlaris Bio, Inc.Not yet recruitingGlaucoma | Normal Tension Glaucoma (NTG) | Low-Tension Glaucoma, Bilateral | Low-Tension Glaucoma, Unspecified EyeKorea, Republic of, Philippines
-
Technische Universität DresdenCompletedNormal Tension Glaucoma | High Tension Glaucoma
-
Helsinki University Central HospitalRecruitingNormal Tension GlaucomaFinland
-
Robert Ritch, MD, LLC.UnknownNormal Tension GlaucomaUnited States
-
University of NebraskaCompletedNormal Tension GlaucomaUnited States
-
Novartis PharmaceuticalsCompleted
-
Umeå UniversityVästerbotten County Council, SwedenCompletedNormal Tension GlaucomaSweden
-
Weill Medical College of Cornell UniversityCompletedNormal Tension GlaucomaUnited States
Clinical Trials on PHP-201 0.25% ophthalmic solution
-
pH PharmaCompletedHealthy VolunteerKorea, Republic of
-
pH PharmaNot yet recruitingPrimary Open Angle Glaucoma | Ocular HypertensionKorea, Republic of
-
Seinda Pharmaceutical Guangzhou CorporationCompleted
-
Aldeyra Therapeutics, Inc.Completed
-
Aldeyra Therapeutics, Inc.Completed
-
Aldeyra Therapeutics, Inc.CompletedAllergic ConjunctivitisUnited States
-
Aldeyra Therapeutics, Inc.CompletedAllergic ConjunctivitisUnited States
-
Aldeyra Therapeutics, Inc.Completed
-
Aldeyra Therapeutics, Inc.CompletedAllergic ConjunctivitisCanada
-
Aldeyra Therapeutics, Inc.CompletedDry Eye SyndromesCanada