NCT03131167

Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open-angle Glaucoma (POAG)
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	SHP639 (n=60)	Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog.
DRUG	Placebo Comparator (n=24)	Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product.

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2017-04-27
• Last updated: 2021-06-08
• Results posted: 2019-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study