A Phase 2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Patients With Pterygium
Overview
- Phase
- Phase 2
- Intervention
- RMP-A03 - Dose 1
- Conditions
- Pterygium
- Sponsor
- Suzhou Raymon Pharmaceuticals Company, Ltd.
- Enrollment
- 77
- Locations
- 6
- Primary Endpoint
- Change from baseline in pterygium hyperemia grading at Day 28
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Patients randomized to dose 1 study drug
Approximately 25 patients randomized to dose 1 of RMP-A03
Intervention: RMP-A03 - Dose 1
Patients randomized to dose 2 of study drug
Approximately 25 patients randomized to dose 2 of RMP-A03
Intervention: RMP-A03 - Dose 2
Patients randomized to placebo
Approximately 25 patients randomized to placebo.
Intervention: RMP-A03 Placebo
Outcomes
Primary Outcomes
Change from baseline in pterygium hyperemia grading at Day 28
Time Frame: 28 days
Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.
Secondary Outcomes
- Change from baseline in pterygium characteristics at Day 28(28 days)