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Completed

NCT Number: NCT05794204

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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Global Research Management, Glendale, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

RMP-A03 - Dose 1

Drug

Patients will randomized to low dose of RMP-A03

RMP-A03 - Dose 2

Drug

Patients will be randomized to high dose of RMP-A03

RMP-A03 Placebo

Drug

Patients will be randomized to RMP-A03 Placebo

Primary outcomes

  1. Change From Baseline in Pterygium Hyperemia Grading at Day 28

    Time frame: 28 days

    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.

Secondary outcomes

  1. Change From Baseline in Pterygium Characteristics at Day 28

    Time frame: 28 days

    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

Sponsors and collaborators

Lead sponsor

Suzhou Raymon Pharmaceuticals Company, Ltd.

Industry

Collaborators

  • WuXi Clinical

Registry information

Official study title

A Phase 1/2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Healthy Volunteers and Patients With Pterygium

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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