Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03131167 | Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma | PHASE1 | COMPLETED | 63 | — | — | May 10, 2017 | May 30, 2018 | Jun 8, 2021 | 1 | United States |
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.
| Arm | Type | Description |
|---|---|---|
| SHP639 Ophthalmic Solution Arm (n=60) | EXPERIMENTAL | Participants are divided into groups called cohorts. There will be approximately 12 cohorts, each consisting of 7 participants. In each cohort 5 out of 7 participants will be assigned a specified concentration of SHP639 (0.1%, 0.3%, or 0.6%) ophthalmic solution and a specific dosing schedule (the study participants will be instructed to insill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Vehicle Ophthalmic Arm (n=24) | PLACEBO_COMPARATOR | In each cohort 2 out of 7 participants will be assigned a placebo ophthalmic solution matched to 0.1%, 0.3%, and 0.6% SHP639 ophthalmic solution and specific dosing schedule (the study participants will be instructed to instill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Name | Type | Description |
|---|---|---|
| SHP639 (n=60) | DRUG | Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog. |
| Placebo Comparator (n=24) | DRUG | Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product. |
Inclusion Criteria: 1. Participants must provide written, signed and dated informed consent to participate in the study in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing any study-related ...