RMP-A03 Ocular Suspension in Patients With Pterygium

NCT05794204 | Completed Phase 2 FDA Drug

• 1 other identifier: RMP-A03-001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in pterygium characteristics at Day 28

  28 days

Study Arms (3)

Patients randomized to dose 1 study drug

EXPERIMENTAL

Approximately 25 patients randomized to dose 1 of RMP-A03

Drug: RMP-A03 - Dose 1

Patients randomized to dose 2 of study drug

EXPERIMENTAL

Approximately 25 patients randomized to dose 2 of RMP-A03

Drug: RMP-A03 - Dose 2

Patients randomized to placebo

PLACEBO COMPARATOR

Approximately 25 patients randomized to placebo.

Drug: RMP-A03 Placebo

Interventions

RMP-A03 - Dose 1 DRUG

Patients will randomized to low dose of RMP-A03

Patients randomized to dose 1 study drug

RMP-A03 - Dose 2 DRUG

Patients will be randomized to high dose of RMP-A03

Patients randomized to dose 2 of study drug

RMP-A03 Placebo DRUG

Patients will be randomized to RMP-A03 Placebo

Patients randomized to placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Suzhou Raymon Pharmaceuticals Company, Ltd.: lead
• WuXi Clinical: collaborator

Study Sites (6)

Global Research Management

Glendale, California, 91204, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Eye Research Foundation Inc

Newport Beach, California, 92663, United States

Location

Oceane7 Medical & Research Center Inc.

Miami, Florida, 33144, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1:1 fashion

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: June 9, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (6)