SHP640-303 study of SHP640 in patients with Bacterial 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 Placebo in the Treatment of Bacterial Conjunctivitis
IRAS ID
223871
Contact name
Felipe Dhawahir-Scala
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc.
Eudract number
2016-003361-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
75,723, IND
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Bacterial conjunctivitis, also called 'pink eye' is the second most common cause of infectious conjunctivitis which affects all populations of all ages and social levels worldwide, 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.
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 SHP640-303 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 bacterial conjunctivitis?
•How does SHP640 compare to PVP-I (povidone-iodine) 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 721 people, of any age, in about 90 sites in 13 countries 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 3:1:3 (SHP640:PVP-I:placebo), to receive either SHP640, PVP-I or placebo. Treatment will be assigned based on patient 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.
All follow-up procedures will be done during the last study centre visit (Visit 5 - Day 12). Any unresolved issues will be followed up by the Study Doctor until closure.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0405
Date of REC Opinion
22 Feb 2018
REC opinion
Further Information Favourable Opinion