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Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106532
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
pH Pharma

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

Condition or disease Intervention/treatment Phase
Normal Tension Glaucoma Drug: PHP-201 0.25% ophthalmic solution Drug: PHP-201 0.5% ophthalmic solution Drug: Placebo ophthalmic solution Phase 2

Detailed Description:
Data collection (electronic case report forms), Data dictionary (MedDRA)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: PHP-201 0.25% ophthalmic solution
PHP-201 0.25% ophthalmic solution, TID
Drug: PHP-201 0.25% ophthalmic solution
3 drops daily, 28 days
Other Name: PHP-201

Experimental: PHP-201 0.5% ophthalmic solution
PHP-201 0.5% ophthalmic solution, TID
Drug: PHP-201 0.5% ophthalmic solution
3 drops daily, 28 days
Other Name: PHP-201

Placebo Comparator: Placebo ophthalmic solution
Placebo ophthalmic solution, TID
Drug: Placebo ophthalmic solution
3 drops daily, 28 days
Other Name: PHP-201




Primary Outcome Measures :
  1. Mean diurnal IOP change [ Time Frame: 4 weeks ]
    Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks


Secondary Outcome Measures :
  1. The number of patient with adverse events [ Time Frame: 28 days ]
    The number of patient with adverse events including ocular adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106532


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
pH Pharma

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Responsible Party: pH Pharma
ClinicalTrials.gov Identifier: NCT03106532     History of Changes
Other Study ID Numbers: PHP-201-S203
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Ophthalmic Solutions
Pharmaceutical Solutions