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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03004924




Registration number
NCT03004924
Ethics application status
Date submitted
19/12/2016
Date registered
29/12/2016

Titles & IDs
Public title
Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
Scientific 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
Secondary ID [1] 0 0
2016-003361-25
Secondary ID [2] 0 0
SHP640-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Conjunctivitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHP640
Treatment: Drugs - PVP-I 0.6%
Treatment: Drugs - Placebo

Experimental: SHP640 - Participants will instill 1 drop of SHP640 (povidone-iodine \[PVP-I\] 0.6 percent \[%\] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

Active comparator: PVP-I 0.6% - Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days

Placebo comparator: Placebo - Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Timepoint [1] 0 0
Day 5
Secondary outcome [1] 0 0
Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
Timepoint [1] 0 0
Baseline, Day 5
Secondary outcome [2] 0 0
Number of Participants With Clinical Resolution
Timepoint [2] 0 0
Day 3, 8 and 12
Secondary outcome [3] 0 0
Number of Participants With Bacterial Eradication
Timepoint [3] 0 0
Day 3, 8 and 12
Secondary outcome [4] 0 0
Bulbar Conjunctival Injection Score
Timepoint [4] 0 0
Day 3, 5, 8 and 12
Secondary outcome [5] 0 0
Change From Baseline in the Bulbar Conjunctival Injection Score
Timepoint [5] 0 0
Baseline, Day 3, 5, 8 and 12
Secondary outcome [6] 0 0
Ocular Conjunctival Discharge Score
Timepoint [6] 0 0
Day 3, 5, 8 and 12
Secondary outcome [7] 0 0
Change From Baseline in the Ocular Conjunctival Discharge Score
Timepoint [7] 0 0
Baseline, Day 3, 5, 8 and 12
Secondary outcome [8] 0 0
Global Clinical Score
Timepoint [8] 0 0
Day 3, 5, 8 and 12
Secondary outcome [9] 0 0
Change From Baseline in the Global Clinical Score
Timepoint [9] 0 0
Baseline, Day 3, 5, 8 and 12
Secondary outcome [10] 0 0
Number of Participants With Modified Clinical Resolution
Timepoint [10] 0 0
Day 3, 5, 8 and 12
Secondary outcome [11] 0 0
Number of Participants With Expanded Clinical Resolution
Timepoint [11] 0 0
Day 3, 5, 8 and 12
Secondary outcome [12] 0 0
Time to Clinical Resolution
Timepoint [12] 0 0
Baseline to Day 12
Secondary outcome [13] 0 0
Number of Participants Who Used Rescue Medication
Timepoint [13] 0 0
Baseline to Day 12
Secondary outcome [14] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [14] 0 0
From start of study drug administration up to 14 days

Eligibility
Key inclusion criteria
* An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
* Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
* Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth).
* Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
* Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:

1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
3. Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale
* Be willing to discontinue contact lens wear for the duration of the study.
* Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of investigator.
* Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
* Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
* Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
* Prior enrollment in a FST-100 or SHP640 clinical study.
* Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
* Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study.
* Have a preplanned overnight hospitalization during the period of the study.
* Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
* Have active or a history of ocular herpes.
* Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
* Neonates or infants (ie, participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
* Neonates or infants (ie, participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
* Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
* Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
* Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect.
* Have any known clinically significant optic nerve defects.
* Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
* Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.
* Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment.
* Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of enrollment.
* Have used any topical ophthalmic steroids in the last <= 14 days.
* Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area.
* Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
* Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
* Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion.
* Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
* Within 30 days prior to the first dose of investigational product:

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
Accrual to date
Final
753
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of the Sunshine Coast Clinical Trials Centre - Sippy Downs
Recruitment postcode(s) [1] 0 0
4556 - Sippy Downs
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
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Massachusetts
Country [16] 0 0
United States of America
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Minnesota
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United States of America
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Missouri
Country [18] 0 0
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Nevada
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New Jersey
Country [20] 0 0
United States of America
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New York
Country [21] 0 0
United States of America
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North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
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Oklahoma
Country [24] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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South Carolina
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South Dakota
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United States of America
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Tennessee
Country [29] 0 0
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Texas
Country [30] 0 0
United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Wisconsin
Country [33] 0 0
Austria
State/province [33] 0 0
Linz
Country [34] 0 0
Austria
State/province [34] 0 0
Vienna
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Haute Vienne
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Hungary
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Csongrad
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Hungary
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Heves
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Hungary
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Debrecen
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Hungary
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Kaposvár
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Hungary
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Veszprem
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Israel
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Afula
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Petah Tikva
Country [49] 0 0
Israel
State/province [49] 0 0
Rehovot
Country [50] 0 0
Israel
State/province [50] 0 0
Tel Aviv
Country [51] 0 0
Italy
State/province [51] 0 0
Bologna
Country [52] 0 0
Poland
State/province [52] 0 0
Malopolska
Country [53] 0 0
Poland
State/province [53] 0 0
Bytom
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Poland
State/province [54] 0 0
Olsztyn
Country [55] 0 0
Poland
State/province [55] 0 0
Tarnów
Country [56] 0 0
Poland
State/province [56] 0 0
Warszawa
Country [57] 0 0
Puerto Rico
State/province [57] 0 0
Arecibo
Country [58] 0 0
Puerto Rico
State/province [58] 0 0
Carolina
Country [59] 0 0
Puerto Rico
State/province [59] 0 0
San Juan
Country [60] 0 0
South Africa
State/province [60] 0 0
Gauteng
Country [61] 0 0
Spain
State/province [61] 0 0
Asturias
Country [62] 0 0
Spain
State/province [62] 0 0
Huelva
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03004924