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

Shire129 sites in 1 country219 target enrollmentMarch 27, 2017

ConditionsAdenoviral Conjunctivitis

InterventionsSHP640 PVP-I 0.6%Placebo

DrugsSHP640 PVP-I 0.6%

Overview

Phase: Phase 3
Intervention: SHP640
Conditions: Adenoviral Conjunctivitis
Sponsor: Shire
Enrollment: 219
Locations: 129
Primary Endpoint: Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 adenoviral conjunctivitis.

Registry

clinicaltrials.gov

Start Date

March 27, 2017

End Date

May 13, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

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 lesser than (\<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (\>=) 37 weeks gestational age at birth).
•Meet at least 1 of the 2 criteria below:
•a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc).
•ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.
•iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.
•Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 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 lesser than or equal to (\<=) 4 days prior to Visit 1
•Bulbar conjunctival injection: a grade of \>= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.

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 participants 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 pre-planned overnight hospitalization during the period of the study.
•Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
•Have presence of corneal subepithelial infiltrates at Visit
•Have active or history of ocular herpes.

Arms & Interventions

SHP640

Participants will receive one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

Intervention: SHP640

PVP-I 0.6%

Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.

Intervention: PVP-I 0.6%

Placebo

Participants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days.

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6

Time Frame: Day 6

Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

Secondary Outcomes

Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6(Day 6)
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3(Day 3)
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6(Day 6)
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)(Day 3, 8 and 12/ET)
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6(Day 6)
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6(Day 6)
Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8(Day 6 and 8)
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)(Day 8 and 12/ET)
Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640(From start of the study up to Day 14)