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CompletedNCT03004924Updated Jun 9, 2021Results posted

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

A Phase 3 interventional study of SHP640 and PVP-I 0.6% in Bacterial Conjunctivitis, sponsored by Shire. Completed at 163 sites in 13 countries. Per ClinicalTrials.gov, last updated 2021-06-09.

Sponsored by Shire · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
753
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Bacterial Conjunctivitis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
753 participants (actual)

Study arms

  • 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.

    Drug: SHP640

  • 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

    Drug: PVP-I 0.6%

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugSHP640

    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.

  • DrugPVP-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.

  • DrugPlacebo

    Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

05

What researchers measure

Primary outcomes

  1. Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on 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%.

    Time frame: Day 5

Secondary outcomes

  1. Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5

    Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

    Time frame: Baseline, Day 5

  2. Number of Participants With Clinical Resolution

    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 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 atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

    Time frame: Day 3, 8 and 12

  3. Number of Participants With Bacterial Eradication

    Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.

    Time frame: Day 3, 8 and 12

  4. Bulbar Conjunctival Injection Score

    Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.

    Time frame: Day 3, 5, 8 and 12

  5. Change From Baseline in the Bulbar Conjunctival Injection Score

    Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.

    Time frame: Baseline, Day 3, 5, 8 and 12

  6. Ocular Conjunctival Discharge Score

    Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

    Time frame: Day 3, 5, 8 and 12

  7. Change From Baseline in the Ocular Conjunctival Discharge Score

    Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

    Time frame: Baseline, Day 3, 5, 8 and 12

  8. Global Clinical Score

    Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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 a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

    Time frame: Day 3, 5, 8 and 12

  9. Change From Baseline in the Global Clinical Score

    Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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 a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

    Time frame: Baseline, Day 3, 5, 8 and 12

  10. Number of Participants With Modified Clinical Resolution

    Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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.

    Time frame: Day 3, 5, 8 and 12

  11. Number of Participants With Expanded Clinical Resolution

    Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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.

    Time frame: Day 3, 5, 8 and 12

  12. Time to Clinical Resolution

    Clinical resolution was defined as absence (score of 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 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. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.

    Time frame: Baseline to Day 12

  13. Number of Participants Who Used Rescue Medication

    Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.

    Time frame: Baseline to Day 12

  14. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.

    Time frame: From start of study drug administration up to 14 days

06

Results

Posted Oct 28, 2019

Participant flow

Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first participant first visit) and 01 Oct 2018 (last participant last visit).

Participant flow — Overall Study
MilestoneSHP640PVP-I 0.6%Placebo
Started324108321
Completed29794293
Not completed271428
Withdrew: Adverse event6510
Withdrew: Protocol violation401
Withdrew: Withdrawal by subject535
Withdrew: Lost to follow-up614
Withdrew: Lack of efficacy242
Withdrew: Physician decision101
Withdrew: Withdrawal by parent/guardian102
Withdrew: Screen failure100
Withdrew: Pregnancy010
Withdrew: Terminated by sponsor001
Withdrew: Missed study visit002
Withdrew: Hsv1 positive100

Outcome measures

PrimaryNumber of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on 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%.

Time frame:
Day 5
Reported as:
Count of participants · Participants
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5111095
Statistical analysis
  • SHP640 vs Placebo · Fisher Exact · p = 0.127 · Difference in response rate: 7.7 · 95% CI -1.6 to 16.9
SecondaryNumber of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5

Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

Time frame:
Baseline, Day 5
Reported as:
Count of participants · Participants
Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5940102
Statistical analysis
  • SHP640 vs Placebo · Fisher Exact · p = 0.500 · Difference in response rate: -3.5 · 95% CI -12.8 to 5.9
SecondaryNumber of Participants With Clinical Resolution

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 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 atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

Time frame:
Day 3, 8 and 12
Reported as:
Count of participants · Participants
Number of Participants With Clinical Resolution
ParticipantsSHP640PVP-I 0.6%Placebo
Day 339639
Day 814839133
Day 1215047154
SecondaryNumber of Participants With Bacterial Eradication

Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.

Time frame:
Day 3, 8 and 12
Reported as:
Count of participants · Participants
Number of Participants With Bacterial Eradication
ParticipantsSHP640PVP-I 0.6%Placebo
Day 3763379
Day 8852587
Day 12832182
SecondaryBulbar Conjunctival Injection Score

Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.

Time frame:
Day 3, 5, 8 and 12
Reported as:
Mean · Score on a scale
Bulbar Conjunctival Injection Score
Score on a scaleSHP640PVP-I 0.6%Placebo
Day 31.0 ± 0.841.3 ± 0.901.1 ± 0.86
Day 50.5 ± 0.770.7 ± 0.880.7 ± 0.80
Day 80.3 ± 0.640.4 ± 0.610.4 ± 0.61
Day 120.2 ± 0.560.2 ± 0.470.2 ± 0.48
SecondaryChange From Baseline in the Bulbar Conjunctival Injection Score

Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.

Time frame:
Baseline, Day 3, 5, 8 and 12
Reported as:
Mean · Score on a scale
Change From Baseline in the Bulbar Conjunctival Injection Score
Score on a scaleSHP640PVP-I 0.6%Placebo
Day 3-1.0 ± 0.77-0.8 ± 0.76-0.9 ± 0.76
Day 5-1.5 ± 0.87-1.3 ± 0.99-1.3 ± 0.85
Day 8-1.8 ± 0.91-1.6 ± 0.86-1.6 ± 0.81
Day 12-1.8 ± 0.89-1.8 ± 0.74-1.8 ± 0.82
SecondaryOcular Conjunctival Discharge Score

Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

Time frame:
Day 3, 5, 8 and 12
Reported as:
Mean · Score on a scale
Ocular Conjunctival Discharge Score
Score on a scaleSHP640PVP-I 0.6%Placebo
Day 30.7 ± 0.730.8 ± 0.740.7 ± 0.76
Day 50.3 ± 0.570.2 ± 0.440.4 ± 0.60
Day 80.1 ± 0.430.1 ± 0.310.2 ± 0.47
Day 120.1 ± 0.490.0 ± 0.220.1 ± 0.28
SecondaryChange From Baseline in the Ocular Conjunctival Discharge Score

Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

Time frame:
Baseline, Day 3, 5, 8 and 12
Reported as:
Mean · Score on a scale
Change From Baseline in the Ocular Conjunctival Discharge Score
Score on a scaleSHP640PVP-I 0.6%Placebo
Day 3-0.9 ± 0.77-0.8 ± 0.67-0.9 ± 0.85
Day 5-1.4 ± 0.74-1.4 ± 0.75-1.3 ± 0.75
Day 8-1.5 ± 0.71-1.5 ± 0.73-1.4 ± 0.74
Day 12-1.5 ± 0.76-1.6 ± 0.71-1.6 ± 0.73
SecondaryGlobal Clinical Score

Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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 a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

Time frame:
Day 3, 5, 8 and 12
Reported as:
Mean · Score on a scale
Global Clinical Score
Score on a scaleSHP640PVP-I 0.6%Placebo
Day 31.7 ± 1.372.1 ± 1.391.9 ± 1.42
Day 50.8 ± 1.180.9 ± 1.191.0 ± 1.18
Day 80.4 ± 0.930.5 ± 0.770.6 ± 0.93
Day 120.4 ± 0.900.3 ± 0.550.3 ± 0.67
SecondaryChange From Baseline in the Global Clinical Score

Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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 a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

Time frame:
Baseline, Day 3, 5, 8 and 12
Reported as:
Mean · Score on a scale
Change From Baseline in the Global Clinical Score
Score on a scaleSHP640PVP-I 0.6%Placebo
Day 3-1.9 ± 1.28-1.6 ± 1.22-1.8 ± 1.30
Day 5-2.9 ± 1.27-2.8 ± 1.47-2.6 ± 1.31
Day 8-3.2 ± 1.36-3.2 ± 1.25-3.1 ± 1.25
Day 12-3.3 ± 1.38-3.4 ± 1.06-3.3 ± 1.23
SecondaryNumber of Participants With Modified Clinical Resolution

Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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.

Time frame:
Day 3, 5, 8 and 12
Reported as:
Count of participants · Participants
Number of Participants With Modified Clinical Resolution
ParticipantsSHP640PVP-I 0.6%Placebo
Day 31002893
Day 516648143
Day 818959175
Day 1218259173
SecondaryNumber of Participants With Expanded Clinical Resolution

Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from 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.

Time frame:
Day 3, 5, 8 and 12
Reported as:
Count of participants · Participants
Number of Participants With Expanded Clinical Resolution
ParticipantsSHP640PVP-I 0.6%Placebo
Day 315546154
Day 518554171
Day 819363192
Day 1218561181
SecondaryTime to Clinical Resolution

Clinical resolution was defined as absence (score of 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 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. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.

Time frame:
Baseline to Day 12
Reported as:
Median · Days
Time to Clinical Resolution
DaysSHP640PVP-I 0.6%Placebo
Time to Clinical Resolution5 (5.0 to 8.0)6 (5.0 to 8.0)8 (5.0 to 8.0)
SecondaryNumber of Participants Who Used Rescue Medication

Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.

Time frame:
Baseline to Day 12
Reported as:
Count of participants · Participants
Number of Participants Who Used Rescue Medication
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants Who Used Rescue Medication234
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.

Time frame:
From start of study drug administration up to 14 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Treatment-emergent Adverse Events (TEAEs)1064361

Adverse events

Collected over From start of study drug administration up to 14 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SHP6400/323 (0%)0/323 (0%)67/323 (20.7%)
PVP-I 0.6%0/108 (0%)0/108 (0%)26/108 (24.1%)
Placebo0/321 (0%)0/321 (0%)7/321 (2.2%)
Most frequent other events
Most frequent other events
EventSHP640PVP-I 0.6%Placebo
Instillation site painGeneral disorders67/32326/1087/321

Baseline characteristics

ITT population included all randomized participants.

Age, Continuous
Age, Continuous(Years)SHP640PVP-I 0.6%PlaceboTotal
Mean44.2 ± 22.8743.1 ± 23.0344.7 ± 23.0044.3 ± 22.92
Sex: Female, Male
Sex: Female, Male(Participants)SHP640PVP-I 0.6%PlaceboTotal
Female19171199461
Male13337122292
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SHP640PVP-I 0.6%PlaceboTotal
Ethnicity — Hispanic or Latino623087179
Ethnicity — Not Hispanic or Latino25476230560
Ethnicity — Not reported4228
Ethnicity — Other4026
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SHP640PVP-I 0.6%PlaceboTotal
Race — American Indian or Alaska Native0134
Race — Asian120820
Race — Black or African American541854126
Race — White25088250588
Race — Native Hawaiian or Other Pacific Islander0022
Race — Other61411
Race — Multiple2002
07

Study locations

163 sites
  • Arizona Eye Center
    Chandler, Arizona 85225, United States
  • Cornea and Cataract Consultants of Arizona
    Phoenix, Arizona 85032, United States
  • M&M Eye Institute
    Prescott, Arizona 86301, United States
  • Schwartz Laser Eye Center
    Scottsdale, Arizona 85260, United States
  • Walman Eye Center
    Sun City, Arizona 85351, United States
  • Milton M. Hom, OD, FAAO
    Azusa, California 91702, United States
  • Clark S Tsai Eye Center
    Concord, California 94520, United States
  • Lugene Eye Institute Inc
    Glendale, California 91204, United States
  • Mark B. Kislinger, MD, Inc.
    Glendora, California 91741, United States
  • Inland Eye Specialists
    Hemet, California 92545, United States
  • Lakeside Vision Center
    Irvine, California 92604, United States
  • Hull Eye Center
    Lancaster, California 93534, United States
  • Eye Physicians of Long Beach
    Long Beach, California 90808, United States
  • Oxford Optical
    Los Angeles, California 90020, United States
  • Sok H. Nam, M.D. Inc.
    Los Angeles, California 90020, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Macy Eye Center
    Los Angeles, California 90048, United States
  • North Valley Eye Medical Group Inc
    Mission Hills, California 91345, United States
  • North Bay Eye Associates, Inc.
    Petaluma, California 94954, United States
  • Arch Health Partners
    Poway, California 92064, United States
  • Martel Eye Medical Group
    Rancho Cordova, California 95670, United States
  • Shasta Eye Medical Group, Inc.
    Redding, California 96001, United States
  • Clinical Trials Research
    Roseville, California 95661, United States
  • Sacramento Eye Consultants
    Sacramento, California 95815, United States
  • WCCT Global (PH 1 Unit)
    Santa Ana, California 92705, United States
  • East West Eye Institute
    Torrance, California 90505, United States
  • Wolstan & Goldberg Eye Associates
    Torrance, California 90505, United States
  • Specialty Eye Care
    Parker, Colorado 80134, United States
  • Danbury Eye Physicians and Surgeons
    Danbury, Connecticut 06810, United States
  • Ophthalmic Consultants of Connecticut
    Meriden, Connecticut 06824, United States
  • Windham Eye Group
    Willimantic, Connecticut 06226, United States
  • The Eye Associates of Manatee, LLP
    Bradenton, Florida 34209, United States
  • Bruce A. Segal, MD, PA
    Delray Beach, Florida 33484, United States
  • South Florida Vision
    Fort Lauderdale, Florida 33309, United States
  • Bowden Eye & Associates
    Jacksonville, Florida 32256, United States
  • Shettle Eye Research, Inc.
    Largo, Florida 33773, United States
  • Millenium Clinical Research
    Miami, Florida 33125, United States
  • Millennium Clinical Research, Inc.
    Miami, Florida 33125, United States
  • South Florida Research Center Inc.
    Miami, Florida 33135, United States
  • Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
  • Lorites Medical Group
    Miami, Florida 33166, United States
  • Pediatric & Adult Research Center, LLC
    Orlando, Florida 32825, United States
  • Medsol Clinical Research Center
    Port Charlotte, Florida 33948, United States
  • Score Physician Alliance, LLC
    Saint Petersburg, Florida 33710, United States
  • East Florida Eye Institute
    Stuart, Florida 34494, United States
  • Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
    Tamarac, Florida 33321, United States
  • Logan Ophthalmic Research, LLC
    Tamarac, Florida 33321, United States
  • International Research Center
    Tampa, Florida 33603, United States
  • Eye Care Centers Management, Inc.
    Morrow, Georgia 30260, United States
  • Jenkins Eye Care
    Honolulu, Hawaii 96814, United States
  • Saltzer Medical Group
    Nampa, Idaho 83686, United States
  • Wohl Eye Center
    Bloomingdale, Illinois 60108, United States
  • Jackson Eye
    Lake Villa, Illinois 60046, United States
  • Illinois Eye Center
    Peoria, Illinois 61615, United States
  • MediSphere Medical Research Center, LLC
    Evansville, Indiana 47714, United States
  • Midwest Cornea Associates, LLC
    Indianapolis, Indiana 46290, United States
  • Sabates Eye Centers
    Leawood, Kansas 66211, United States
  • Kannarr Eye Care
    Pittsburg, Kansas 66762, United States
  • Cincinnati Eye Institute
    Edgewood, Kentucky 41017, United States
  • Koffler Vision Group
    Lexington, Kentucky 40509, United States
  • Kentucky Eye Institute
    Lexington, Kentucky 40517, United States
  • The Eye Care Institute
    Louisville, Kentucky 40206, United States
  • Dr. Haider Eye Care
    Louisville, Kentucky 40220, United States
  • Senior Health Services
    Louisville, Kentucky 40220, United States
  • Baker, Carl W
    Paducah, Kentucky 42001, United States
  • Lakeview Vision
    Gretna, Louisiana 70056, United States
  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
    West Monroe, Louisiana 71291, United States
  • Eye Center Northeast
    Bangor, Maine 04401, United States
  • Massachusetts Eye and Ear Infirmary
    Boston, Massachusetts 02114, United States
  • NECCR PrimaCare Research
    Fall River, Massachusetts 02721, United States
  • Shire Call Center
    Lexington, Massachusetts 02421, United States
  • Clinical Eye Research of Boston
    Winchester, Massachusetts 02114, United States
  • Minnesota Eye Consultants, P.A
    Bloomington, Minnesota 55431, United States
  • Lifelong Vision Foundation
    Chesterfield, Missouri 63017, United States
  • Silverstein Eye Centers
    Kansas City, Missouri 64133, United States
  • Moyes Eye Center
    Kansas City, Missouri 64154, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Tekwani Vision Center
    Saint Louis, Missouri 63128, United States
  • Ophthalmology Associates
    Saint Louis, Missouri 63131, United States
  • Opthalmology Consultants Ltd.
    Saint Louis, Missouri 63131, United States
  • Mercy Research
    Springfield, Missouri 65806, United States
  • NV Eye Physicians
    Henderson, Nevada 89074, United States
  • Wellish Vision Institute
    Las Vegas, Nevada 89119, United States
  • Emil A. Stein, M.D., Ltd.
    Las Vegas, Nevada 89129, United States
  • Hassman Research Institute
    Berlin, New Jersey 08009, United States
  • Northern New Jersey Eye Institute
    South Orange, New Jersey 07079, United States
  • Farkas, Kassalow, Resnick &Associates
    New York, New York 10022, United States
  • Fichte, Endl& Elmer Eyecare
    Niagara Falls, New York 14304, United States
  • South Shore Eye Care
    Wantagh, New York 11793, United States
  • Oculus Research at Garner EyeCareCenter
    Raleigh, North Carolina 27603, United States
  • James Branch, M.D.
    Winston-Salem, North Carolina 27101, United States
  • Apex Eye Kenwood
    Cincinnati, Ohio 45236, United States
  • Cincinnati Eye Institute
    Cincinnati, Ohio 45242, United States
  • Apex Eye
    Cincinnati, Ohio 45247, United States
  • Cleveland Eye Clinic
    Cleveland, Ohio 44141, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • The Columbus Eye Center
    Columbus, Ohio 43215, United States
  • SkyVision Centers
    Westlake, Ohio 44145, United States
  • IPS Research Company*
    Oklahoma City, Oklahoma 73120, United States
  • Pacific Clear Vision Institute
    Eugene, Oregon 97401, United States

Showing the first 100 of 163 sites across 13 countries.

08

References and documents

Study documents

  • Study protocol · Sep 27, 2016
  • Study protocol · Nov 28, 2016
  • Study protocol · Feb 15, 2017
  • Study protocol · Dec 13, 2017
  • Study protocol · Jul 31, 2018
  • Statistical analysis plan · Nov 8, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Sap, Icf, Csr

09

Registry details

Key details

Study ID
NCT03004924
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Dec 29, 2016
Start date
Mar 29, 2017
Primary completion
Oct 1, 2018
Completion
Oct 1, 2018
Results posted
Oct 28, 2019
Last update
Jun 9, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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