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| Name | Class |
|---|---|
| WuXi Clinical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients randomized to dose 1 study drug | Experimental | Approximately 25 patients randomized to dose 1 of RMP-A03 |
|
| Patients randomized to dose 2 of study drug | Experimental | Approximately 25 patients randomized to dose 2 of RMP-A03 |
|
| Patients randomized to placebo | Placebo Comparator | Approximately 25 patients randomized to placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RMP-A03 - Dose 1 | Drug | Patients will randomized to low dose of RMP-A03 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management | Glendale | California | 91204 | United States | ||
| United Medical Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Patients Randomized to Placebo | Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Patients Randomized to Dose 2 of Study Drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| mITT Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 28 days |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis allergic | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sen Wang | Suzhou Raymon Pharmaceuticals | (0086)-0512-67238910 | sen.wang@raymonpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2023 | Apr 16, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2024 | Apr 16, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2022 | Apr 16, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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Patients will be randomized in a 1:1:1 fashion
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Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.
| RMP-A03 - Dose 2 | Drug | Patients will be randomized to high dose of RMP-A03 |
|
| RMP-A03 Placebo | Drug | Patients will be randomized to RMP-A03 Placebo |
|
| Inglewood |
| California |
| 90301 |
| United States |
| Eye Research Foundation Inc | Newport Beach | California | 92663 | United States |
| Oceane7 Medical & Research Center Inc. | Miami | Florida | 33144 | United States |
| Toyos Clinic | Nashville | Tennessee | 37215 | United States |
| Keystone Research | Austin | Texas | 78731 | United States |
Approximately 25 patients randomized to dose 2 of RMP-A03
RMP-A03 - Dose 2: Patients will be randomized to high dose of RMP-A03
| BG002 | Patients Randomized to Placebo | Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 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 |
| OG001 | 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 |
| OG002 | Patients Randomized to Placebo | Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo |
|
|
| Secondary | 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 | mITT Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale (mm) | 28 days |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 6 |
| 26 |
| EG001 | 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 | 0 | 26 | 0 | 26 | 5 | 26 |
| EG002 | Patients Randomized to Placebo | Approximately 25 patients randomized to placebo. RMP-A03 Placebo: Patients will be randomized to RMP-A03 Placebo | 0 | 25 | 0 | 25 | 5 | 25 |
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Eye pruritus | Eye disorders | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
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