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Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

NCT03004924 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 753

Last updated 2021-06-09

Study results available
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Summary

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

Conditions

  • Bacterial Conjunctivitis

Interventions

DRUG

SHP640

Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.

DRUG

PVP-I 0.6%

Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

DRUG

Placebo

Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2018-10-01
Completion
2018-10-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Estonia
  • France
  • Hungary
  • Israel
  • Italy
  • Poland
  • Puerto Rico
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT03004924 on ClinicalTrials.gov