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NCT05794204 Clinical Trial

RMP-A03 Ocular Suspension in Patients With Pterygium

Pterygium Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05794204
Other study ID # RMP-A03-001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 9, 2023
Est. completion date July 2024

Study information
Verified date April 2024
Source Suzhou Raymon Pharmaceuticals Company, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• RMP-A03 - Dose 1
Patients will randomized to dose 1 of RMP-A03
• RMP-A03 - Dose 2
Patients will be randomized to dose 2 of RMP-A03
• RMP-A03 Placebo
Patients will be randomized to RMP-A03 Placebo

Locations
Country Name City State
United States Keystone Research Austin Texas
United States Global Research Management Glendale California
United States United Medical Research Institute Inglewood California
United States Oceane7 Medical & Research Center Inc. Miami Florida
United States Toyos Clinic Nashville Tennessee
United States Eye Research Foundation Inc Newport Beach California

Sponsors (2)
Lead Sponsor Collaborator
Suzhou Raymon Pharmaceuticals Company, Ltd. WuXi Clinical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in pterygium hyperemia grading at Day 28 Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale. 28 days
Secondary Change from baseline in pterygium characteristics at Day 28 Pterygium size will be measured by the principal investigator based on predefined scale 28 days
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