RMP-A03 Ocular Suspension in Patients With Pterygium

NCT ID: NCT05794204

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2024-01-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized in a 1:1:1 fashion
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.

Study Groups

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Patients randomized to dose 1 study drug

Approximately 25 patients randomized to dose 1 of RMP-A03

Group Type EXPERIMENTAL

RMP-A03 - Dose 1

Intervention Type DRUG

Patients will randomized to low dose of RMP-A03

Patients randomized to dose 2 of study drug

Approximately 25 patients randomized to dose 2 of RMP-A03

Group Type EXPERIMENTAL

RMP-A03 - Dose 2

Intervention Type DRUG

Patients will be randomized to high dose of RMP-A03

Patients randomized to placebo

Approximately 25 patients randomized to placebo.

Group Type PLACEBO_COMPARATOR

RMP-A03 Placebo

Intervention Type DRUG

Patients will be randomized to RMP-A03 Placebo

Interventions

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RMP-A03 - Dose 1

Patients will randomized to low dose of RMP-A03

Intervention Type DRUG

RMP-A03 - Dose 2

Patients will be randomized to high dose of RMP-A03

Intervention Type DRUG

RMP-A03 Placebo

Patients will be randomized to RMP-A03 Placebo

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WuXi Clinical

INDUSTRY

Sponsor Role collaborator

Suzhou Raymon Pharmaceuticals Company, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Global Research Management

Glendale, California, United States

Site Status

United Medical Research Institute

Inglewood, California, United States

Site Status

Eye Research Foundation Inc

Newport Beach, California, United States

Site Status

Oceane7 Medical & Research Center Inc.

Miami, Florida, United States

Site Status

Toyos Clinic

Nashville, Tennessee, United States

Site Status

Keystone Research

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RMP-A03-001

Identifier Type: -

Identifier Source: org_study_id