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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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).

Related Conditions & MeSH terms

• Pterygium

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