SHP640-301 study of SHP640 in patients with Adenoviral Conjunctivitis

  • Research type

    Research Study

  • Full title

    A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

  • IRAS ID

    223875

  • Contact name

    Felipe Dhawahir-Scala

  • Contact email

    Felipe.Dhawahir-Scala@cmft.nhs.uk

  • Sponsor organisation

    Shire Human Genetic Therapies, Inc.

  • Eudract number

    2016-002439-14

  • Clinicaltrials.gov Identifier

    NCT02998541

  • Clinicaltrials.gov Identifier

    75,723, IND

  • Duration of Study in the UK

    0 years, 3 months, 1 days

  • Research summary

    Conjunctivitis, also called ‘pink eye’, is an inflammation of the conjunctiva of the eye, and can be categorised as either non-infectious or infectious depending on the cause. Conjunctivitis affects all populations worldwide of all ages and social levels, irrespective of gender. ‘Pink eye’ is a temporary infection that causes signs and symptoms such as redness, watering/discharge, irritation, or soreness of the eyes, and it can be associated with discomfort lasting a few days or weeks. The infection is most often caused by viruses called “adenoviruses” or bacteria and can be passed very easily from person to person. Adenoviral conjunctivitis may account for up to 80% of all conjunctivitis cases in adults.
    This study is part of the SHP640 program, also called the Synchronize research studies, which is looking at a potential new drug that targets both causes of conjunctivitis.
    SHP640 is a non-antibiotic, novel topical ophthalmic (medication that is applied to eye) suspension which is currently under development for the treatment of infectious conjunctivitis (adenoviral and bacterial).
    The purpose of this SHP633-301 study is to help answer the following question(s):
    •How safe is SHP640 and what the side effects are that might be related to it?
    •Can SHP640 help patients with adenoviral conjunctivitis?
    •How does SHP640 compare to PVP-I and/or placebo? A placebo is a look-alike treatment that has no active drug in it. PVP-I is one of the two active ingredients in SHP640.
    About 930 people, of any age, in about 100 sites in 4 regions are expected to take part in this study.
    Patient’s will be in the study for about 13 days and will need to visit the study centre a total of 5 times.
    At Visit 1 (Day 1) all eligible patients will be assigned randomly, at the ratio 2:2:1 (SHP640:PVP-I:placebo), to receive either SHP640, PVP-I or placebo. Treatment assignment will be stratified by age to ensure similar number of patients are allocated to each treatment arm within following age groups: patients <6 years, 6 to <18 years and patients ≥18 years of age.
    During Visit 1 patients will receive the first dose of IMP and will be instructed to instil 1 drop of investigational product in each eye 4 times a day (with a minimum of 2 hours between doses) for 7 days.

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference

    17/EM/0404

  • Date of REC Opinion

    22 Feb 2018

  • REC opinion

    Further Information Favourable Opinion