A Phase 2 interventional study of RMP-A03 - Dose 1 and RMP-A03 - Dose 2 in Pterygium, sponsored by Suzhou Raymon Pharmaceuticals Company, Ltd.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Suzhou Raymon Pharmaceuticals Company, Ltd. · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 77 is above the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →This is the only study on the registry with Suzhou Raymon Pharmaceuticals Company, Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 25 patients randomized to dose 1 of RMP-A03
Drug: RMP-A03 - Dose 1
Approximately 25 patients randomized to dose 2 of RMP-A03
Drug: RMP-A03 - Dose 2
Approximately 25 patients randomized to placebo.
Drug: RMP-A03 Placebo
Patients will randomized to low dose of RMP-A03
Patients will be randomized to high dose of RMP-A03
Patients will be randomized to RMP-A03 Placebo
Change From Baseline in Pterygium Hyperemia Grading at Day 28
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.
Time frame: 28 days
Change From Baseline in Pterygium Characteristics at Day 28
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
Time frame: 28 days
| Milestone | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo |
|---|---|---|---|
| Started | 26 | 26 | 25 |
| Completed | 25 | 24 | 25 |
| Not completed | 1 | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
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.
| units on a scale | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo |
|---|---|---|---|
| Change From Baseline in Pterygium Hyperemia Grading at Day 28 | -0.32 (-0.54 to -0.10) | -0.09 (-0.32 to 0.13) | -0.30 (-0.53 to -0.08) |
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
| units on a scale (mm) | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo |
|---|---|---|---|
| Change From Baseline in Pterygium Characteristics at Day 28 | 0.02 (-0.23 to 0.27) | -0.14 (-0.39 to 0.11) | -0.01 (-0.27 to 0.24) |
Collected over Treatment-emergent adverse events were collected over approximately 3 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Randomized to Dose 1 Study Drug | 0/26 (0%) | 0/26 (0%) | 6/26 (23.1%) |
| Patients Randomized to Dose 2 of Study Drug | 0/26 (0%) | 0/26 (0%) | 5/26 (19.2%) |
| Patients Randomized to Placebo | 0/25 (0%) | 0/25 (0%) | 5/25 (20%) |
| Event | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo |
|---|---|---|---|
| Eye pruritusEye disorders | 0/26 | 2/26 | 1/25 |
| Blepharitis allergicEye disorders | 0/26 | 0/26 | 1/25 |
| Foreign body sensation in eyesEye disorders | 0/26 | 1/26 | 1/25 |
| Ocular hyperaemiaEye disorders | 0/26 | 0/26 | 1/25 |
| Vision blurredEye disorders | 1/26 | 0/26 | 1/25 |
| Conjunctival hyperaemiaEye disorders | 1/26 | 0/26 | 0/25 |
| Conjunctivitis allergicEye disorders | 1/26 | 0/26 | 0/25 |
| Eye painEye disorders | 1/26 | 0/26 | 0/25 |
| Lacrimation increasedEye disorders | 1/26 | 1/26 | 0/25 |
| NauseaGastrointestinal disorders | 1/26 | 0/26 | 0/25 |
ITT Analysis Set
| Age, Continuous(Years) | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo | Total |
|---|---|---|---|---|
| Mean | 52.2 ± 15.28 | 53.1 ± 9.89 | 55.2 ± 10.39 | 53.5 ± 12.03 |
| Sex: Female, Male(Participants) | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo | Total |
|---|---|---|---|---|
| Female | 10 | 9 | 7 | 26 |
| Male | 16 | 17 | 18 | 51 |
| Race (NIH/OMB)(Participants) | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 1 | 9 |
| White | 22 | 22 | 23 | 67 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Patients Randomized to Dose 1 Study Drug | Patients Randomized to Dose 2 of Study Drug | Patients Randomized to Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 21 | 19 | 21 | 61 |
| Not Hispanic or Latino | 5 | 7 | 4 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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