Trial Outcomes & Findings for RMP-A03 Ocular Suspension in Patients With Pterygium (NCT NCT05794204)

Last Updated: 2026-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

28 days

Results posted on

2026-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	26	26	25
Overall Study COMPLETED	25	24	25
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

RMP-A03 Ocular Suspension in Patients With Pterygium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Randomized to Dose 1 Study Drug n=26 Participants 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 n=26 Participants 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 n=25 Participants Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo	Total n=77 Participants Total of all reporting groups
Age, Continuous	52.2 Years STANDARD_DEVIATION 15.28 • n=20 Participants	53.1 Years STANDARD_DEVIATION 9.89 • n=20 Participants	55.2 Years STANDARD_DEVIATION 10.39 • n=40 Participants	53.5 Years STANDARD_DEVIATION 12.03 • n=6 Participants
Sex: Female, Male Female	10 Participants n=20 Participants	9 Participants n=20 Participants	7 Participants n=40 Participants	26 Participants n=6 Participants
Sex: Female, Male Male	16 Participants n=20 Participants	17 Participants n=20 Participants	18 Participants n=40 Participants	51 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	4 Participants n=20 Participants	4 Participants n=20 Participants	1 Participants n=40 Participants	9 Participants n=6 Participants
Race (NIH/OMB) White	22 Participants n=20 Participants	22 Participants n=20 Participants	23 Participants n=40 Participants	67 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=20 Participants	19 Participants n=20 Participants	21 Participants n=40 Participants	61 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=20 Participants	7 Participants n=20 Participants	4 Participants n=40 Participants	16 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: 28 days

Population: mITT Analysis Set

Outcome measures

Outcome measures
Measure	Patients Randomized to Dose 2 of Study Drug n=24 Participants 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 n=25 Participants Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo	Patients Randomized to Dose 1 Study Drug n=26 Participants Approximately 25 patients randomized to dose 1 of RMP-A03 RMP-A03 - Dose 1: Patients will randomized to low dose of RMP-A03
Change From Baseline in Pterygium Hyperemia Grading at Day 28	-0.09 units on a scale Interval -0.32 to 0.13	-0.30 units on a scale Interval -0.53 to -0.08	-0.32 units on a scale Interval -0.54 to -0.1

SECONDARY outcome

Timeframe: 28 days

Population: mITT Analysis Set

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

Outcome measures

Outcome measures
Measure	Patients Randomized to Dose 2 of Study Drug n=24 Participants 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 n=25 Participants Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo	Patients Randomized to Dose 1 Study Drug n=26 Participants Approximately 25 patients randomized to dose 1 of RMP-A03 RMP-A03 - Dose 1: Patients will randomized to low dose of RMP-A03
Change From Baseline in Pterygium Characteristics at Day 28	-0.14 units on a scale (mm) Interval -0.39 to 0.11	-0.01 units on a scale (mm) Interval -0.27 to 0.24	0.02 units on a scale (mm) Interval -0.23 to 0.27

Adverse Events

Patients Randomized to Dose 1 Study Drug

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Patients Randomized to Dose 2 of Study Drug

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Patients Randomized to Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Randomized to Dose 1 Study Drug n=26 participants at risk 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 n=26 participants at risk 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 n=25 participants at risk Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo
Eye disorders Blepharitis allergic	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Conjunctival hyperaemia	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Conjunctivitis allergic	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Eye pain	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Eye pruritus	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	7.7% 2/26 • Number of events 3 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Foreign body sensation in eyes	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Lacrimation increased	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Ocular hyperaemia	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	4.0% 1/25 • Number of events 2 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Eye disorders Vision blurred	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Gastrointestinal disorders Nausea	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Infections and infestations COVID-19	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.
Infections and infestations Nasopharyngitis	0.00% 0/26 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.	0.00% 0/25 • Treatment-emergent adverse events were collected over approximately 3 months An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and does not imply any judgment about causality.

Additional Information

Sen Wang

Suzhou Raymon Pharmaceuticals

Phone: (0086)-0512-67238910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60