Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2023-06-09
2024-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Patients randomized to dose 1 study drug
Approximately 25 patients randomized to dose 1 of RMP-A03
RMP-A03 - Dose 1
Patients will randomized to low dose of RMP-A03
Patients randomized to dose 2 of study drug
Approximately 25 patients randomized to dose 2 of RMP-A03
RMP-A03 - Dose 2
Patients will be randomized to high dose of RMP-A03
Patients randomized to placebo
Approximately 25 patients randomized to placebo.
RMP-A03 Placebo
Patients will be randomized to RMP-A03 Placebo
Interventions
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RMP-A03 - Dose 1
Patients will randomized to low dose of RMP-A03
RMP-A03 - Dose 2
Patients will be randomized to high dose of RMP-A03
RMP-A03 Placebo
Patients will be randomized to RMP-A03 Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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WuXi Clinical
INDUSTRY
Suzhou Raymon Pharmaceuticals Company, Ltd.
INDUSTRY
Responsible Party
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Locations
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Global Research Management
Glendale, California, United States
United Medical Research Institute
Inglewood, California, United States
Eye Research Foundation Inc
Newport Beach, California, United States
Oceane7 Medical & Research Center Inc.
Miami, Florida, United States
Toyos Clinic
Nashville, Tennessee, United States
Keystone Research
Austin, Texas, United States
Countries
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Other Identifiers
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RMP-A03-001
Identifier Type: -
Identifier Source: org_study_id