PterygiumPhase 2NCT05794204
RMP-A03 Ocular Suspension in Patients With Pterygium
A Phase 2 study testing RMP-A03 - Dose 1 and RMP-A03 - Dose 2 in people with Pterygium, run by Suzhou Raymon Pharmaceuticals Company, Ltd. at 6 sites in United States.
Trial summary
The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- RMP-A03 - Dose 1 and RMP-A03 - Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Jun 2023to 12 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of ocular disease
- Double pterygium
- History of ocular surgery
- Presence of ocular trauma
- Use of any ocular medication
- Use of contact lens
Show all 11Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Keystone Research
Austin, Texas, 78731
Global Research Management
Glendale, California, 91204
United Medical Research Institute
Inglewood, California, 90301
Oceane7 Medical & Research Center Inc.
Miami, Florida, 33144
Toyos Clinic
Nashville, Tennessee, 37215
Eye Research Foundation Inc
Newport Beach, California, 92663
About this study
Official title: A Phase 1/2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Healthy Volunteers and Patients With Pterygium
The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.
Read the 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.
- Conditions
- Pterygium
- Being tested
- RMP-A03 - Dose 1, RMP-A03 - Dose 2, RMP-A03 Placebo
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMP-A03 - Dose 1Drug
Patients will randomized to low dose of RMP-A03
RMP-A03 - Dose 2Drug
Patients will be randomized to high dose of RMP-A03
RMP-A03 PlaceboDrug
Patients will be randomized to RMP-A03 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Patients randomized to dose 1 study drug | Experimental | Approximately 25 patients randomized to dose 1 of RMP-A03 Receives: Drug: RMP-A03 - Dose 1 |
| Patients randomized to dose 2 of study drug | Experimental | Approximately 25 patients randomized to dose 2 of RMP-A03 Receives: Drug: RMP-A03 - Dose 2 |
| Patients randomized to placebo | Placebo comparator | Approximately 25 patients randomized to placebo. Receives: Drug: RMP-A03 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = Trace; pterygium translucent and difficult to distinguish from surrounding conjunctiva; episcleral vessels easily visible; minimally dilated vessels with slight density increase
- = Mild; the pterygium pink in color; vessels dilated with mild density increase; slight obstructionwith episceral vessels still distinguishable.
- = Moderate; pterygium red in color and thicker than surrounding conjunctiva; vessels engorged; some white scleral tissue visible; episcleral vessels obscured \& indistinguishable.
- = 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.
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start9 Jun 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1:1 fashion
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Raymon Pharmaceuticals Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WuXi Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794204
- Sponsor's protocol ID
- RMP-A03-001
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2023
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Healthy Volunteers and Patients With Pterygium
- ClinicalTrials.gov ID
- NCT05794204
- Acronym / sponsor ID
- RMP-A03-001
- Conditions
- Pterygium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Suzhou Raymon Pharmaceuticals Company, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- WuXi Clinical
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized in a 1:1:1 fashion
| Arm | Type | Receives |
|---|---|---|
| Patients randomized to dose 1 study drug | Experimental | Drug: RMP-A03 - Dose 1Approximately 25 patients randomized to dose 1 of RMP-A03 |
| Patients randomized to dose 2 of study drug | Experimental | Drug: RMP-A03 - Dose 2Approximately 25 patients randomized to dose 2 of RMP-A03 |
| Patients randomized to placebo | Placebo comparator | Drug: RMP-A03 PlaceboApproximately 25 patients randomized to placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Presence of ocular disease
- Double pterygium
- History of ocular surgery
- Presence of ocular trauma
- Use of any ocular medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RMP-A03 - Dose 1Patients will randomized to low dose of RMP-A03 | Drug | Patients randomized to dose 1 study drug |
| RMP-A03 - Dose 2Patients will be randomized to high dose of RMP-A03 | Drug | Patients randomized to dose 2 of study drug |
| RMP-A03 PlaceboPatients will be randomized to RMP-A03 Placebo | Drug | Patients randomized to placebo |
Primary outcome
Change From Baseline in Pterygium Hyperemia Grading at Day 28
Time frame: 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.
1 secondary outcome
Change From Baseline in Pterygium Characteristics at Day 28
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RMP-A03 - Dose 1 and RMP-A03 - Dose 2 in people with Pterygium, run by Suzhou Raymon Pharmaceuticals Company, Ltd. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pterygium Hyperemia Grading at Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.