RMP-A03 Ocular Suspension in Patients With Pterygium

April 15, 2024 updated by: Suzhou Raymon Pharmaceuticals Company, Ltd.

A Phase 2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Patients With Pterygium

The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

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 Contact

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91204
        • Global Research Management
      • Inglewood, California, United States, 90301
        • United Medical Research Institute
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation Inc
    • Florida
      • Miami, Florida, United States, 33144
        • Oceane7 Medical & Research Center Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Toyos Clinic
    • Texas
      • Austin, Texas, United States, 78731
        • Keystone Research

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients randomized to dose 1 study drug
Approximately 25 patients randomized to dose 1 of RMP-A03
Drug: RMP-A03 - Dose 1
Patients will randomized to dose 1 of RMP-A03
Experimental: Patients randomized to dose 2 of study drug
Approximately 25 patients randomized to dose 2 of RMP-A03
Drug: RMP-A03 - Dose 2
Patients will be randomized to dose 2 of RMP-A03
Placebo Comparator: Patients randomized to placebo
Approximately 25 patients randomized to placebo.
Drug: RMP-A03 Placebo
Patients will be randomized to RMP-A03 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pterygium hyperemia grading at Day 28
Time Frame: 28 days
Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pterygium characteristics at Day 28
Time Frame: 28 days
Pterygium size will be measured by the principal investigator based on predefined scale
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Raymon Pharmaceuticals Company, Ltd.

Collaborators

WuXi Clinical

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)

June 9, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMP-A03-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

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