At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 63 enrolled
Drug / intervention
SHP639 (n=60) +1 moredrug
Likely dose
SHP639 topical ophthalmic solution, dose to be determined (Phase 1 ascending dose study)AI-extracted
Key inclusion· 5
- ✓Age 18–90 years at time of consent
- ✓Ocular hypertension or stable early primary open-angle glaucoma in both eyes with acceptable Humphrey visual fields (false-positive rate ≤25%, false-negative rate ≤25%, fixation loss ≤33%, mean deviation no worse than −6.00 dB)
- ✓Mean IOP ≥24 mmHg at 8:00 AM and ≥22 mmHg at 10:00 AM in at least one eye, with IOP difference <4 mmHg between eyes at both time points on Day −1
- ✓Best-corrected visual acuity ≥65 letters on the Early Treatment Diabetic Retinopathy Study chart (Snellen equivalent ~20/60) in both eyes at screening and baseline
Key exclusion· 12
- ✕Anatomically narrow angle, synechiae, angle closure glaucoma, normal tension glaucoma, pseudoexfoliation syndrome, pigmentary dispersion syndrome, or secondary glaucoma
- ✕Corneal endothelial cell count <2000 cells/mm² measured by noncontact specular microscopy
- ✕Central corneal thickness <500 μm or >620 μm
- ✕IOP >32 mmHg in either eye before randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-masked, Placebo-controlled Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Daily and Multiple Daily Ascending Doses of SHP639 Topical Ophthalmic Solution in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma (POAG)
In Brief
A Phase 1 clinical trial evaluating SHP639 (n=60) and Placebo Comparator (n=24) for Primary Open-angle Glaucoma (POAG) and Ocular Hypertension. Completed, enrolled 63 participants across 1 site.
Detailed Summary
Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionMay 2018
TodayJul 2026
First PostedApr 27, 2017
Enrollment StartMay 10, 2017
Primary CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.2 years ago
Interventions
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.