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

Shire161 sites in 1 country753 target enrollmentMarch 29, 2017

ConditionsBacterial Conjunctivitis

InterventionsSHP640 PVP-I 0.6%Placebo

Overview

Phase: Phase 3
Intervention: SHP640
Conditions: Bacterial Conjunctivitis
Sponsor: Shire
Enrollment: 753
Locations: 161
Primary Endpoint: Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Status: Completed
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 bacterial conjunctivitis.

Registry

clinicaltrials.gov

Start Date

March 29, 2017

End Date

October 1, 2018

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 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
•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:
•Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (\<=) 4 days prior to Visit 1
•Bulbar conjunctival injection: a grade of \>= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
•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.

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.

Arms & Interventions

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.

Intervention: SHP640

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

Intervention: PVP-I 0.6%

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5

Time Frame: Day 5

Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

Secondary Outcomes

Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5(Baseline, Day 5)
Change From Baseline in the Bulbar Conjunctival Injection Score(Baseline, Day 3, 5, 8 and 12)
Number of Participants With Modified Clinical Resolution(Day 3, 5, 8 and 12)
Number of Participants With Clinical Resolution(Day 3, 8 and 12)
Global Clinical Score(Day 3, 5, 8 and 12)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From start of study drug administration up to 14 days)
Number of Participants With Bacterial Eradication(Day 3, 8 and 12)
Bulbar Conjunctival Injection Score(Day 3, 5, 8 and 12)
Ocular Conjunctival Discharge Score(Day 3, 5, 8 and 12)
Change From Baseline in the Ocular Conjunctival Discharge Score(Baseline, Day 3, 5, 8 and 12)
Change From Baseline in the Global Clinical Score(Baseline, Day 3, 5, 8 and 12)
Number of Participants With Expanded Clinical Resolution(Day 3, 5, 8 and 12)
Time to Clinical Resolution(Baseline to Day 12)
Number of Participants Who Used Rescue Medication(Baseline to Day 12)