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

NCT03131167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-06-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2018-05-30
Completion
2018-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131167 on ClinicalTrials.gov