RMP-A03 Ocular Suspension in Patients With Pterygium

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

Detailed Description
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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.

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

Conditions
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Pterygium

Intervention / Treatment
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* Drug: RMP-A03 - Dose 1
* Drug: RMP-A03 - Dose 2
* Drug: RMP-A03 Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in a 1:1:1 fashion
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pterygium characteristics at Day 28 | Pterygium size will be measured by the principal investigator based on predefined scale | 28 days |