Pterygium
Conditions
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.
Interventions
DRUGRMP-A03 - Dose 1
Patients will randomized to low dose of RMP-A03
DRUGRMP-A03 - Dose 2
Patients will be randomized to high dose of RMP-A03
DRUGRMP-A03 Placebo
Patients will be randomized to RMP-A03 Placebo
Sponsors
Suzhou Raymon Pharmaceuticals Company, Ltd.
WuXi Clinical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Patients will be randomized in a 1:1:1 fashion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pterygium Hyperemia Grading at Day 28 | 28 days | Pterygium hyperemia grading will be assessed by the principal investigator using the slitlamp and anterior photography, based on the predefined vascularity scale as follows: 0 = no pterygium tissue present; no fibrovascular tissue crossing the cornea limbus 1. = Trace; pterygium translucent and difficult to distinguish from surrounding conjunctiva; episcleral vessels easily visible; minimally dilated vessels with slight density increase 2. = Mild; the pterygium pink in color; vessels dilated with mild density increase; slight obstructionwith episceral vessels still distinguishable. 3. = Moderate; pterygium red in color and thicker than surrounding conjunctiva; vessels engorged; some white scleral tissue visible; episcleral vessels obscured \& indistinguishable. 4. = Severe; pterygium deep, bright, and diffusely red; severe vessel density increase; vessels engorged; no white scleral tissue visualized; episcleral vessels \& tissues obscured by network of vessels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pterygium Characteristics at Day 28 | 28 days | Pterygium length will be measured by the principal investigator on the slitlamp. The length of the pterygium is measured from the a) conjunctiva where the pterygium tissue with dilated blood vessels that can be distinguished from the surrounding conjunctiva to b) where the head of encroachment ends on the cornea |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.2 Years STANDARD_DEVIATION 15.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 6 / 26 | 5 / 26 | 5 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 25 |
Outcome results
None listed