RMP-A03 Ocular Suspension in Patients With Pterygium

Suzhou Raymon Pharmaceuticals Company, Ltd.77 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pterygium

Interventions

RMP-A03 - Dose 1DRUG

Patients will randomized to low dose of RMP-A03

RMP-A03 - Dose 2DRUG

Patients will be randomized to high dose of RMP-A03

RMP-A03 PlaceboDRUG

Patients will be randomized to RMP-A03 Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (6)

Global Research Management

Glendale, California, United States

United Medical Research Institute

Inglewood, California, United States

Eye Research Foundation Inc

Newport Beach, California, United States

Oceane7 Medical & Research Center Inc.

Miami, Florida, United States

Outcomes

Primary Outcomes

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 1. = Trace; pterygium translucent and difficult to distinguish from surrounding conjunctiva; episcleral vessels easily visible; minimally dilated vessels with slight density increase 2. = Mild; the pterygium pink in color; vessels dilated with mild density increase; slight obstructionwith episceral vessels still distinguishable. 3. = Moderate; pterygium red in color and thicker than surrounding conjunctiva; vessels engorged; some white scleral tissue visible; episcleral vessels obscured \& indistinguishable. 4. = 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.

Time frame: 28 days

Secondary Outcomes

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

Time frame: 28 days

Data from ClinicalTrials.gov

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