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Submitted by: Quintiles 2018-04-25 00:00:00 Last Updated by: Quintiles 2020-07-03 16:23:04


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

PHRR180425-001827

SHP640-301

2017-CT0435

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

SHP640-301 is a phase III, global, multi-center, randomized, double-masked, parallel group, placebo controlled study designed to demonstrate the safety and efficacy of SHP640 ophthalmic suspension compared to PVP-I 0.6% ophthalmic solution and to placebo in treating adenoviral conjunctivitis.
 
SHP640, a novel topical ophthalmic suspension, is currently under development for the treatment of infectious conjunctivitis (adenoviral and bacterial). SHP640 contains two active ingredients –dexamethasone 0.1% and PVP-I (povidone iodine) 0.6%.
 
Approximately 930 subjects will be randomized into the study. Subjects will be randomized 2:2:1 to receive either SHP640, PVP-I, or placebo within each stratum. Randomization will be stratified by age to maintain the randomization ratio among subjects < 6 years, 6 to
 
The purpose of this 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 subjects with adenoviral conjunctivitis?
• How does SHP640 compare to PVP-I and/or placebo? 

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Drug discovery and development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-07-31 18 2020-01-31 2019-06-13

Terminated

based on the to prioritize Sponsor's portfolio based on its scientific and business judgments. There are no safety concerns.

Institution Classification Region LTO #
SHIRE Private Business United States of America Not Applicable
Institution Classification Region LTO #
Quintiles Philippines, Inc. Private Business NCR CDRR-NCR-CRO-2
Institution Region
SHIRE United States of America
Name E-Mail Institution and Institution Address
Elena Lam QMNL.HealthRegistrymailbox@quintiles.com Unit 7A 7th Floor 8 Rockwell Buidling, Hidalgo Drive Makati City
Name E-Mail Institution and Institution Address
Abhijit Narvekar anarvekar0@shire.com Shire 300 Shire Way, Lexington, MA 02421 USA
Name Expertise Affiliation
Cheryl Arcinue, MD Ophthalmology Asian Eye Institute
Edward Uy, MD Ophthalmology Makati Medical Center
Harvey Uy, MD Ophthalmology Peregrine Eye and Laser Institute
Jeffrey Lim, MD Ophthalmology Cebu Doctors' University Hospital
Manolette Roque, MD Ophthalmology Makati Medical Center
Patricia Khu, MD Ophthalmology Cardinal Santos Medical Center
Richard Raymund Nepomuceno, MD Ophthalmology Philippine General Hospital
Victor Caparas, MD Ophthalmology The Medical City
Project Location Institutional Ethics Review Board
Asian Eye Institute Asian Eye Institute Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board
Peregrine Eye and Laser Institute Peregrine Eye and Laser Institute Institutional Review Board
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
The Medical City The Medical City - Institutional Review Board

Adenoviral Conjunctivitis is an inflammation of the conjunctiva of the eye caused due to infectious and inflammatory components of conjunctivitis resulting from adenovirus (the most common cause for viral
conjunctivitis),  It is a self-limiting condition, but some types of conjunctivitis progress and may cause serious ocular and extraocular complications. Adenoviral conjunctivitis is typically spread through direct contact between the eye and hands that are contaminated with the virus via contact with infected eye discharge, fecal matter, or respiratory discharge.

The primary outcome of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and watery conjunctival discharge) compared with placebo in the treatment of subjects with adenoviral conjunctivitis in
the study eye at Visit 3 (Day 6).

Key secondary outcome of this study are as follows:
• To evaluate the efficacy of SHP640 based on clinical resolution compared with PVP-I in the
treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 3 (Day 6).
 
• To evaluate the efficacy of PVP-I based on adenoviral eradication (defined as negative cell culture-immunofluorescence assay [CC-IFA]) compared with placebo in the treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 2 (Day 3).
 
• To evaluate the efficacy of SHP640 based on adenoviral eradication compared with placebo in the treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 3 (Day 6).
 
• To evaluate the efficacy of SHP640 based on adenoviral eradication compared with PVP-I in the treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 3 (Day 6).
 
• To evaluate the efficacy of PVP-I based on clinical resolution compared with placebo in the treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 3 (Day 6).

Pending

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

Clinical Trial

SHP640-301

20171215145539

2018-03-09

0000-00-00

16

Unspecified

Unspecified

31 Jul 2018

Inclusion Criteria:                                                                                                                         1. An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
2. 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.
3. Subjects of any age at Visit 1 (Note: subjects
4. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
• Report presence of signs and/or symptoms of adenoviral conjunctivitis for ≤ 3 days prior to Visit 1 • Bulbar conjunctival injection: a grade of ≥1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
• Watery conjunctival discharge: a grade of ≥1 (mild) on a 0-3 Watery Conjunctival Discharge Scale
6. Be willing to discontinue contact lens wear for the duration of the study.
7. 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 subjects
8. 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. 
Exclusion Criteria:
Subjects are excluded from the study if any of the following exclusion criteria are met. 
1. 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.
2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. 
4. Prior enrollment in a FST-100 or SHP640 clinical study.
5. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
6. Have a history of ocular surgical intervention within ≤6 months prior to Visit 1 or planned for the period of the study.
7. Have a preplanned overnight hospitalization during the period of the study.
8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
9. Have presence of corneal subepithelial infiltrates at Visit 1.
10. Have active or history of ocular herpes.
11. Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebal, other or parasitic).
12. Neonates or infants (ie. subjects 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.
13. Neonates or infants (ie. subjects 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.
14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
15. 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.
16. Be a known intraocular pressure (IOP) steroid responder, have a known history of glaucoma,
be a glaucoma suspect, or have a known history of an elevated IOP > 21 mmHg.
17. Have any known clinically significant optic nerve defects.
18. 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.
19. Presence of significant, active condition in the posterior segment which requires invasive
treatment (eg, intravitreal treatment with VEGF inhibitors or corticosteroids) and may
progress during the study participation period.
20. Have used any topical ocular or systemic anti-virals or antibiotics within ≤ 7 days of
enrollment.
21. Have used any topical ocular NSAIDs within ≤1 day of enrollment.
22. Have used any topical ophthalmic steroids in the last ≤14 days.
23. 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 peri-ocular area.
24. Have used non-corticosteroid immunosuppressive agents within ≤14 days of Day 1.
25. 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.
26. 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.
27. 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 (antihepatitis A virus immunoglobulin M), or organ or bone marrow
transplantation.
28. Within 30 days prior to the first dose of investigational product:
> 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

Interventional

SHP640 (PVP-I 0.6% and dexamethasone 0.1%) ophthalmic suspension

Three test products will be used in the clinical development program. The drug product is SHP640 (0.1% Dexamethasone and 0.6% PVP-I) Ophthalmic Suspension, the comparator is 0.6% PVP-I Ophthalmic Solution, and the placebo product is Placebo Ophthalmic Solution. Each of these test products are manufactured aseptically and filled in sterile plastic ophthalmic bottles. The placebo contains 2 additional ingredients relative to the others: Benzalkonium Chloride, USP, EP, used as a preservative, and Caramel Color, NF, included to match the dark brown color of the PVP-I active ingredient.
 
Subjects will be randomized 2:2:1 to receive either SHP640, PVP-I, or placebo within each stratum.
Randomization will be stratified by age to maintain the randomization ratio among subjects < 6 years, 6 to

Date Amendment Classification Reason
2018-06-21 Amendments related to the protocol [1] Clinical Study Protocol Version 5.0 dated 17 Jul 2017; [2] ICF (1) English Subject Information Sheet and Informed Consent Form V5.1.PHL01 dated 19 Aug 2017 (2) Tagalog Subject Information Sheet and Informed Consent Form V5.1.PHL(TG)01 dated 10 Jan 2018 (3) Cebuano Subject Information Sheet and Informed Consent Form V5.1.PHL(CB)01 dated 10 Jan 2018
2018-12-27 Amendments related to the protocol

Randomized

Double Blind

Unspecified

Parallel

The primary purpose of this study is to evaluate the efficacy of SHP640 based on clinical resolution compared with placebo in the treatment of subjects with adenoviral conjunctivitis in
the study eye at Visit 3 (Day 6).

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
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