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Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

NCT02998541 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2021-06-14

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 adenoviral conjunctivitis.

Conditions

  • Adenoviral Conjunctivitis

Interventions

DRUG

SHP640

Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.

DRUG

PVP-I 0.6%

Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

OTHER

Placebo

Participants will receive one drop of placebo ophthalmic solution in each eye 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
2017-03-27
Primary Completion
2019-05-13
Completion
2019-05-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Peru
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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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 NCT02998541 on ClinicalTrials.gov