CClinicalTrials.gg
Sign In
TerminatedNCT02998541Updated Jun 14, 2021Results posted

Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

A Phase 3 interventional study of SHP640 and PVP-I 0.6% in Adenoviral Conjunctivitis, sponsored by Shire. Terminated at 130 sites in 16 countries. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Shire · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor decision, unrelated to safety
Phase
Phase 3
Study type
Interventional
Enrollment
219
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 adenoviral conjunctivitis.

02

Conditions studied

  • Adenoviral Conjunctivitis

Browse trials for

03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 219 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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 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:

    1. Report presence of signs and/or symptoms of adenoviral conjunctivitis for lesser than or equal to (\<=) 4 days prior to Visit 1
    2. Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
    3. Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 Watery 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 the 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 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 1.
  • Have active or 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-adenoviral ocular infection (e.g. bacterial, 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 (i.e. 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 (i.e. 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 (e.g. 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 which requires invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
  • Have used any topical ocular or systemic anti-vials or antibiotics within \<= 7 days of enrollment.
  • Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) 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 peri-ocular 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 the 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 (antihepatitis 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
05

Study design

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

Study arms

  • Experimental
    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.

    Drug: SHP640

  • Active comparator
    PVP-I 0.6%

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

    Drug: PVP-I 0.6%

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • DrugSHP640

    Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.

    Also known as: FST-100

  • DrugPVP-I 0.6%

    Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

  • OtherPlacebo

    Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

06

What researchers measure

Primary outcomes

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

    Time frame: Day 6

Secondary outcomes

  1. Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on 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 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 PVP-I 0.6% reporting groups only but not in placebo.

    Time frame: Day 6

  2. Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on 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 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 PVP-I 0.6% and placebo reporting groups only but not in SHP640.

    Time frame: Day 6

  3. Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3

    Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.

    Time frame: Day 3

  4. Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6

    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

    Time frame: Day 6

  5. Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6

    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.

    Time frame: Day 6

  6. Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8

    qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.

    Time frame: Day 6 and 8

  7. Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)

    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

    Time frame: Day 8 and 12/ET

  8. Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)

    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 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.

    Time frame: Day 3, 8 and 12/ET

  9. Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)

    The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.

    Time frame: Day 3, 6, 8 and 12/ET

  10. 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)

    Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

    Time frame: Day 3, 6, 8 and 12/ET

  11. Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)

    Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

    Time frame: Day 3, 6, 8 and 12/ET

  12. Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)

    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 the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

    Time frame: Day 3, 6, 8 and 12/ET

  13. Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)

    Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.

    Time frame: Day 3, 6, 8 and 12/ET

  14. Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)

    Time to clinical resolution were reported based on the assessments in the study eye.

    Time frame: Day 3, 6, 8 and 12/ET

  15. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640

    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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.

    Time frame: From start of the study up to Day 14

07

Results

Posted May 27, 2020
Limitations and caveats
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety.

Participant flow

This study was conducted at 97 sites in 15 countries between 27 March 2017 (first participant enrolled) to 13 May 2019 (last participant completed).

Participant flow — Overall Study
MilestoneSHP640PVP-I 0.6%Placebo
Started869043
Completed788137
Not completed896
Withdrew: Adverse event451
Withdrew: Protocol violation100
Withdrew: Withdrawal by subject310
Withdrew: Lost to follow-up031
Withdrew: Physician decision003
Withdrew: Withdrawal by parent/guardian001

Outcome measures

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

Time frame:
Day 6
Reported as:
Count of participants · Participants
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6301
SecondaryNumber of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on 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 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 PVP-I 0.6% reporting groups only but not in placebo.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6310
SecondaryNumber of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on 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 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 PVP-I 0.6% and placebo reporting groups only but not in SHP640.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6011
SecondaryNumber of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3

Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.

Time frame:
Day 3
Reported as:
Count of participants · Participants
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3082
SecondaryNumber of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6

Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 61407
SecondaryNumber of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6

Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
ParticipantsSHP640PVP-I 0.6%Placebo
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 614200
SecondaryPercent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8

qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.

Time frame:
Day 6 and 8

No measurements were reported for this outcome.

SecondaryNumber of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)

Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

Time frame:
Day 8 and 12/ET
Reported as:
Count of participants · Participants
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)
ParticipantsSHP640PVP-I 0.6%Placebo
Day 8202213
Day 12/ET282813
SecondaryNumber of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)

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 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.

Time frame:
Day 3, 8 and 12/ET
Reported as:
Count of participants · Participants
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
ParticipantsSHP640PVP-I 0.6%Placebo
Day 3000
Day 8653
Day 12/ET20138
SecondaryChange From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)

The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.

Time frame:
Day 3, 6, 8 and 12/ET

No measurements were reported for this outcome.

SecondaryNumber 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)

Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

Time frame:
Day 3, 6, 8 and 12/ET
Reported as:
Count of participants · Participants
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)
ParticipantsSHP640PVP-I 0.6%Placebo
Day 31557
Day 6222011
Day 8242313
Day 12/ET302712
SecondaryNumber of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)

Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

Time frame:
Day 3, 6, 8 and 12/ET

No measurements were reported for this outcome.

SecondaryNumber of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)

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 the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

Time frame:
Day 3, 6, 8 and 12/ET

No measurements were reported for this outcome.

SecondaryNumber of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)

Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.

Time frame:
Day 3, 6, 8 and 12/ET

No measurements were reported for this outcome.

SecondaryTime to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)

Time to clinical resolution were reported based on the assessments in the study eye.

Time frame:
Day 3, 6, 8 and 12/ET

No measurements were reported for this outcome.

SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640

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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.

Time frame:
From start of the study up to Day 14
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
ParticipantsSHP640PVP-I 0.6%Placebo
Treatment-Emergent Adverse Events232810
Serious Adverse Event010

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
SHP6400/86 (0%)0/86 (0%)12/86 (14%)
PVP-I 0.6%0/90 (0%)1/90 (1.1%)8/90 (8.9%)
Placebo0/41 (0%)0/41 (0%)1/41 (2.4%)
Most frequent serious events
Most frequent serious events
EventSHP640PVP-I 0.6%Placebo
Pneumonia bacterialInfections and infestations0/861/900/41
Most frequent other events
Most frequent other events
EventSHP640PVP-I 0.6%Placebo
Instillation site painGeneral disorders12/868/901/41

Baseline characteristics

Intent-To-Treat (ITT) population consisted of all screened participants who were randomized.

Age, Continuous
Age, Continuous(Years)SHP640PVP-I 0.6%PlaceboTotal
Mean41.3 ± 19.5642.7 ± 21.4343.4 ± 23.6742.3 ± 21.10
Sex: Female, Male
Sex: Female, Male(Participants)SHP640PVP-I 0.6%PlaceboTotal
Female464724117
Male404319102
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SHP640PVP-I 0.6%PlaceboTotal
Hispanic or Latino23161049
Not Hispanic or Latino637331167
Unknown or Not Reported0123
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SHP640PVP-I 0.6%PlaceboTotal
American Indian or Alaska Native0202
Asian1411530
Native Hawaiian or Other Pacific Islander0000
Black or African American911525
White626430156
More than one race0033
Unknown or Not Reported1203
08

Study locations

130 sites
  • Arizona Eye Center
    Chandler, Arizona 85224, United States
  • Midwestern University Eye Institute
    Glendale, Arizona 85308, United States
  • M&M Eye Institute
    Prescott, Arizona 86301, United States
  • Walman Eye Center
    Sun City, Arizona 85351, United States
  • Milton M. Hom, OD, FAAO
    Azusa, California 91702, United States
  • Mark B. Kislinger, MD, PhD, Inc.
    Glendora, California 91741, United States
  • Inland Eye Specialists
    Hemet, California 92545, United States
  • Lakeside Vision Center
    Irvine, California 92604, United States
  • Loma Linda University
    Loma Linda, California 92354, United States
  • Eye Physicians of Long Beach
    Long Beach, California 90808, United States
  • Oxford Optical
    Los Angeles, California 90020, United States
  • Macy Eye Center
    Los Angeles, California 90048, United States
  • Shultz Chang Vision
    Northridge, California 91325, United States
  • Stanford Byers Eye Institute
    Palo Alto, California 94303, 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 96002, United States
  • The Eye Associates
    Bradenton, Florida 34209, United States
  • South Florida Vision Associates, LLC
    Fort Lauderdale, Florida 33309, 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
  • East Florida Eye Institute
    Stuart, Florida 34494, United States
  • Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
    Tamarac, Florida 33321, United States
  • Eye Care Centers Management, Inc.
    Morrow, Georgia 30260, United States
  • Jackson Eye
    Lake Villa, Illinois 60046, United States
  • Illinois Eye Center
    Peoria, Illinois 61615, United States
  • MediSphere Medical Research Center, an AMR affiliate
    Evansville, Indiana 47714, United States
  • Kannarr Eye Care
    Pittsburg, Kansas 66762, United States
  • Koffler Vision Group
    Lexington, Kentucky 40509, United States
  • Kentucky Eye Institute
    Lexington, Kentucky 40517, United States
  • Senior Health Services
    Louisville, Kentucky 40220, United States
  • Baker, Carl W
    Paducah, Kentucky 42001, United States
  • Lakeview Vision - Gretna
    Gretna, Louisiana 70056, United States
  • 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
  • Shire Call Center
    Lexington, Massachusetts 02421, United States
  • Clinical Eye Research of Boston
    Winchester, Massachusetts 02114, United States
  • The Regents of the University of Michigan
    Ann Arbor, Michigan 48105, United States
  • Minnesota Eye Consultants, P.A.
    Bloomington, Minnesota 55431, United States
  • Lifelong Vision Foundation
    Chesterfield, Missouri 63017, United States
  • Moyes Eye Center
    Kansas City, Missouri 64154, United States
  • Mercy Research
    Springfield, Missouri 65806, United States
  • Nevada Eye Care Professionals
    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
  • Oculus Research
    Raleigh, North Carolina 27603, United States
  • James Branch, M.D.
    Winston-Salem, North Carolina 27101, United States
  • Matossian Eye Associates
    Doylestown, Pennsylvania 18902, United States
  • UPMC Eye Center
    Pittsburgh, Pennsylvania 15213, United States
  • Wyomissing Optometric Center
    Wyomissing, Pennsylvania 19610, United States
  • Black Hills Regional Eye Institute
    Rapid City, South Dakota 59101, United States
  • The Eye Center at Southern College of Optometry
    Memphis, Tennessee 38104, United States
  • Total Eye Care, PA
    Memphis, Tennessee 38119, United States
  • Eye Specialty Group
    Memphis, Tennessee 38120, United States
  • Nashville Vision Associates
    Nashville, Tennessee 37205, United States
  • Toyos Clinic
    Nashville, Tennessee 37215, United States
  • Houston Eye Associates
    Houston, Texas 77025, United States
  • Lake Travis Eye & Laser Center
    Lakeway, Texas 78734, United States
  • Houston Eye Associates
    League City, Texas 77573, United States
  • DCT-Shah Research, LLC dba Discovery Clinical Trials
    Mission, Texas 78572, United States
  • R and R Eye Research, LLC.
    San Antonio, Texas 78229, United States
  • Lone Star Eye Care, P.A.
    Sugar Land, Texas 77479, United States
  • Ericksen Research & Development, LLC
    Clinton, Utah 84015, United States
  • Emerson Clinical Research Institute, LLC
    Falls Church, Virginia 22046, United States
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
  • University of the Sunshine Coast Clinical Trials Centre
    Sippy Downs, Queensland 4556, Australia
  • Kepler Universitätsklinikum
    Linz, 4020, Austria
  • AKH - Medizinische Universitaet Wien
    Vienna, 1090, Austria
  • Vienna Institute for Research in Ocular Surgery
    Vienna, 1140, Austria
  • The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
    Ottawa, Ontario K1H 8L6, Canada
  • University of Waterloo School of Optometry and Vision Science
    Waterloo, Ontario N2L 3G1, Canada
  • McGill University Health Centre/Glen Site / Royal Victoria Hospital
    Montreal, Quebec H4A 3S5, Canada
  • Eye Clinic Dr Kirsta Turman
    Tallinn, 10120, Estonia
  • East Tallinn Central Hospital
    Tallinn, 10138, Estonia
  • Tartu University Hospital
    Tartu, 51010, Estonia
  • CHU Limoges - Hopital Dupuytren
    Limoges, Haute Vienne 87042, France
  • Hopital Necker - Enfants Malades
    Paris, 75015, France
  • Klinisches Studienzentrum der Augenklinik
    Mainz, 55131, Germany
  • Augenärzte am Franziskus Hospital
    Muenster, 48145, Germany
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    Szeged, Csongrad 6720, Hungary
  • Bugat Pal Korhaz
    Gyongyos, Heves 3200, Hungary
  • Debreceni Egyetem
    Debrecen, 4032, Hungary
  • Somogy Megyei Kaposi Mor Oktato Korhaz
    Kaposvár, 7400, Hungary
  • Csolnoky Ferenc Korhaz
    Veszprem, 8200, Hungary
  • L. V. Prasad Eye Institute
    Hyderabad, Andhra Pradesh 500034, India
  • Sankara Eye Hospital
    Bangalore, Karnataka 560037, India
  • Bhagwan Mahaveer Jain Hospital
    Bangalore, Karnataka 560052, India
  • M. S. Ramaiah Medical College and Hospital
    Bangalore, Karnataka 560054, India
  • Sapthagiri Hospital
    Bangalore, Karnataka 560090, India
  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
    Belgaum, Karnataka 590010, India
  • NKP Salve Institute of Medical Sciences
    Nagpur, Maharashtra 440025, India
  • Dr. D. Y. Patil Medical College
    Navi Mumbai, Maharashtra 400706, India
  • PBMA'S H. V. Desai Eye Hospital
    Pune, Maharashtra 411060, India
  • S. P. Medical College & Associated Group of Hospitals
    Bikaner, Rajasthan 334003, India
  • ICARE Eye Hospital and Post Graduate Institute
    Noida, Uttar Pradesh 201301, India
  • Regional Institute of Ophthalmology
    Kolkata, West Bengal 700073, India
  • HaEmek Medical Center
    Afula, 18341, Israel

Showing the first 100 of 130 sites across 16 countries.

09

References and documents

Study documents

  • Study protocol · Jun 30, 2016
  • Study protocol · Nov 28, 2016
  • Study protocol · Feb 15, 2017
  • Study protocol · Dec 13, 2017
  • Statistical analysis plan · Jun 24, 2019

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02998541
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Dec 20, 2016
Start date
Mar 27, 2017
Primary completion
May 13, 2019
Completion
May 13, 2019
Results posted
May 27, 2020
Last update
Jun 14, 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 terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Conjunctivitis, Inclusion

Other studies from this sponsor

Shire

Start the discussion