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RMP-A03 Ocular Suspension in Patients With Pterygium

Primary Purpose

Pterygium

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
RMP-A03 - Dose 1
RMP-A03 - Dose 2
RMP-A03 Placebo
Sponsored by
Suzhou Raymon Pharmaceuticals Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be at least 18 years old Diagnosis of pterygium with specified characteristics BCVA of 20/200 or better Willingness to attend all study visits and comply with the study procedures Exclusion Criteria: Presence of ocular disease Double pterygium History of ocular surgery Presence of ocular trauma Use of any ocular medication Use of contact lens Allergy to any of the components of study drug Cannot properly administer study drug Clinically significant systemic disease that may place the subject at risk or confound study results Participation in an investigational study within 30 days prior to screening Female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (WOCBP).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Patients randomized to dose 1 study drug

    Patients randomized to dose 2 of study drug

    Patients randomized to placebo

    Arm Description

    Approximately 25 patients randomized to dose 1 of RMP-A03

    Approximately 25 patients randomized to dose 2 of RMP-A03

    Approximately 25 patients randomized to placebo.

    Outcomes

    Primary Outcome Measures

    Change from baseline in pterygium hyperemia grading at Day 28
    Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.

    Secondary Outcome Measures

    Change from baseline in pterygium characteristics at Day 28
    Pterygium size will be measured by the principal investigator based on predefined scale

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    March 20, 2023
    Sponsor
    Suzhou Raymon Pharmaceuticals Company, Ltd.
    Collaborators
    WuXi Clinical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05794204
    Brief Title
    RMP-A03 Ocular Suspension in Patients With Pterygium
    Official Title
    A Phase 2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Patients With Pterygium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Suzhou Raymon Pharmaceuticals Company, Ltd.
    Collaborators
    WuXi Clinical

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.
    Detailed Description
    Following informed consent, patients with pterygium who meet all eligibility criteria will be randomized to an 84-day double-blinded study to measure the safety and efficacy of the study drug as compared to placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pterygium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized in a 1:1:1 fashion
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients randomized to dose 1 study drug
    Arm Type
    Experimental
    Arm Description
    Approximately 25 patients randomized to dose 1 of RMP-A03
    Arm Title
    Patients randomized to dose 2 of study drug
    Arm Type
    Experimental
    Arm Description
    Approximately 25 patients randomized to dose 2 of RMP-A03
    Arm Title
    Patients randomized to placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Approximately 25 patients randomized to placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    RMP-A03 - Dose 1
    Intervention Description
    Patients will randomized to dose 1 of RMP-A03
    Intervention Type
    Drug
    Intervention Name(s)
    RMP-A03 - Dose 2
    Intervention Description
    Patients will be randomized to dose 2 of RMP-A03
    Intervention Type
    Drug
    Intervention Name(s)
    RMP-A03 Placebo
    Intervention Description
    Patients will be randomized to RMP-A03 Placebo
    Primary Outcome Measure Information:
    Title
    Change from baseline in pterygium hyperemia grading at Day 28
    Description
    Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Change from baseline in pterygium characteristics at Day 28
    Description
    Pterygium size will be measured by the principal investigator based on predefined scale
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be at least 18 years old Diagnosis of pterygium with specified characteristics BCVA of 20/200 or better Willingness to attend all study visits and comply with the study procedures Exclusion Criteria: Presence of ocular disease Double pterygium History of ocular surgery Presence of ocular trauma Use of any ocular medication Use of contact lens Allergy to any of the components of study drug Cannot properly administer study drug Clinically significant systemic disease that may place the subject at risk or confound study results Participation in an investigational study within 30 days prior to screening Female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (WOCBP).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashlea Beck
    Phone
    512-284-0103
    Email
    ashlea.beck@raymonpharma.com

    12. IPD Sharing Statement

    Learn more about this trial

    RMP-A03 Ocular Suspension in Patients With Pterygium

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