CompletedPhase 3

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

United States, Australia, Austria753 participantsStarted 2017-03-29

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (\<=) 4 days prior to Visit 1
. Bulbar conjunctival injection: a grade of \>= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
. Ocular conjunctival discharge: a grade of \>= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale

Exclusion criteria

. Have used an investigational product or device, or
. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5

Timeframe: Day 5

Trial details

NCT IDNCT03004924

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-01

Results submitted2019-09-24

View on ClinicalTrials.gov More Bacterial Conjunctivitis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (\<=) 4 days prior to Visit 1
. Bulbar conjunctival injection: a grade of \>= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
. Ocular conjunctival discharge: a grade of \>= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale

Exclusion criteria

. Have used an investigational product or device, or
. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.