RMP-A03 Ocular Suspension in Patients With Pterygium

A Phase 1/2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Healthy Volunteers and 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: Completed
• Conditions: Pterygium
• Intervention / Treatment: Drug: RMP-A03 Placebo; Drug: RMP-A03 - Dose 1; Drug: RMP-A03 - Dose 2

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 (Actual): 77
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

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 low dose 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 high dose 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	Pterygium hyperemia grading will be assessed by the principal investigator using the slitlamp and anterior photography, based on the predefined vascularity scale as follows: 0 = no pterygium tissue present; no fibrovascular tissue crossing the cornea limbus; = Trace; pterygium translucent and difficult to distinguish from surrounding conjunctiva; episcleral vessels easily visible; minimally dilated vessels with slight density increase; = Mild; the pterygium pink in color; vessels dilated with mild density increase; slight obstructionwith episceral vessels still distinguishable.; = Moderate; pterygium red in color and thicker than surrounding conjunctiva; vessels engorged; some white scleral tissue visible; episcleral vessels obscured & indistinguishable.; = Severe; pterygium deep, bright, and diffusely red; severe vessel density increase; vessels engorged; no white scleral tissue visualized; episcleral vessels & tissues obscured by network of vessels.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Pterygium Characteristics at Day 28	Pterygium length will be measured by the principal investigator on the slitlamp. The length of the pterygium is measured from the a) conjunctiva where the pterygium tissue with dilated blood vessels that can be distinguished from the surrounding conjunctiva to b) where the head of encroachment ends on the cornea	28 days

Collaborators and Investigators

• Sponsor: Suzhou Raymon Pharmaceuticals Company, Ltd.
• Collaborators: WuXi Clinical

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 12, 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): June 5, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium
• 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