RMP-A03 Ocular Suspension in Patients With Pterygium

Sponsor

Suzhou Raymon Pharmaceuticals Company, Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05794204

Collaborator

WuXi Clinical (Other)

Enrollment

Arms

10.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Drug: RMP-A03 - Dose 1 Drug: RMP-A03 - Dose 2 Drug: RMP-A03 Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized in a 1:1:1 fashionPatients will be randomized in a 1:1:1 fashion

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients randomized to dose 1 study drug Approximately 25 patients randomized to dose 1 of RMP-A03	Drug: RMP-A03 - Dose 1 Patients will randomized to dose 1 of RMP-A03
Experimental: Patients randomized to dose 2 of study drug Approximately 25 patients randomized to dose 2 of RMP-A03	Drug: RMP-A03 - Dose 2 Patients will be randomized to dose 2 of RMP-A03
Placebo Comparator: Patients randomized to placebo Approximately 25 patients randomized to placebo.	Drug: RMP-A03 Placebo Patients will be randomized to RMP-A03 Placebo

Arm

Intervention/Treatment

Experimental: Patients randomized to dose 1 study drug

Approximately 25 patients randomized to dose 1 of RMP-A03

Drug: RMP-A03 - Dose 1

Patients will randomized to dose 1 of RMP-A03

Experimental: Patients randomized to dose 2 of study drug

Approximately 25 patients randomized to dose 2 of RMP-A03

Drug: RMP-A03 - Dose 2

Patients will be randomized to dose 2 of RMP-A03

Placebo Comparator: Patients randomized to placebo

Approximately 25 patients randomized to placebo.

Drug: RMP-A03 Placebo

Patients will be randomized to RMP-A03 Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Suzhou Raymon Pharmaceuticals Company, Ltd.
WuXi Clinical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzhou Raymon Pharmaceuticals Company, Ltd.

ClinicalTrials.gov Identifier:

NCT05794204

Other Study ID Numbers:

RMP-A03-001

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pterygium

Study Results

No Results Posted as of Apr 3, 2023