RMP-A03 Ocular Suspension in Patients With Pterygium

Phase 2

Completed

• Conditions: Pterygium
• Interventions: Drug: RMP-A03 - Dose 1; Drug: RMP-A03 - Dose 2; Drug: RMP-A03 Placebo

• Registration Number: NCT05794204
• Lead Sponsor: Suzhou Raymon Pharmaceuticals Company, Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-04-03
• Study Start: 2023-06-09
• Primary Completion: 2024-01-12
• Study Completion: 2024-01-12
• Disposition First Posted: 2024-04-16
• Status Verified: 2024-12
• Disposition First Submitted: 2024-12-02
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients randomized to dose 1 study drug	RMP-A03 - Dose 1	Approximately 25 patients randomized to dose 1 of RMP-A03
Patients randomized to dose 2 of study drug	RMP-A03 - Dose 2	Approximately 25 patients randomized to dose 2 of RMP-A03
Patients randomized to placebo	RMP-A03 Placebo	Approximately 25 patients randomized to placebo.

Primary Outcome Measures

Name	Time	Method
Change from baseline in pterygium hyperemia grading at Day 28	28 days	Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pterygium characteristics at Day 28	28 days	Pterygium size will be measured by the principal investigator based on predefined scale

Trial Locations

Locations (6)

Eye Research Foundation Inc; 🇺🇸 Newport Beach, California, United States

Toyos Clinic; 🇺🇸 Nashville, Tennessee, 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

Keystone Research; 🇺🇸 Austin, Texas, United States