RMP-A03 Ocular Suspension in Patients With Pterygium

Suzhou Raymon Pharmaceuticals Company

Status and phase: Active, not recruiting; Phase 2

Conditions: Pterygium

Treatments: Drug: RMP-A03 - Dose 1; Drug: RMP-A03 - Dose 2; Drug: RMP-A03 Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05794204

RMP-A03-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Patients randomized to dose 1 study drug

Experimental group

Description:

Approximately 25 patients randomized to dose 1 of RMP-A03

Treatment:

Drug: RMP-A03 - Dose 1

Patients randomized to dose 2 of study drug

Experimental group

Description:

Approximately 25 patients randomized to dose 2 of RMP-A03

Treatment:

Drug: RMP-A03 - Dose 2

Patients randomized to placebo

Placebo Comparator group

Description:

Approximately 25 patients randomized to placebo.

Treatment:

Drug: RMP-A03 Placebo