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TerminatedNCT02998554Updated Jun 9, 2021Results posted

Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo

A Phase 3 interventional study of SHP640 and Placebo in Adenoviral Conjunctivitis, sponsored by Shire. Terminated at 31 sites in 2 countries. Per ClinicalTrials.gov, last updated 2021-06-09.

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
156
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to determine if an investigational treatment is effective compared with placebo 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 156 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

  1. An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
  2. Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally-authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
  3. 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 greater than or equal to (>=) 37 weeks gestational age at birth).

  4. 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 (example: 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 1 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 4a (a positive AdenoPlus test in at least 1 eye), then the same eye must meet Inclusion Criterion 5.

  5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: Report presence of signs and/or symptoms of adenoviral conjunctivitis for 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; Watery conjunctival discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale.
  6. Be willing to discontinue contact lens wear for the duration of the study.
  7. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the American Academy of Pediatrics (AAP) Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians. 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.
  8. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion criteria

Exclusion Criteria

  1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
  2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
  3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  4. Prior enrollment in a FST-100 or SHP640 clinical study.
  5. Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  6. Have a history of ocular surgical intervention within \<= 6 months prior to Visit 1 or planned for the period of the study.
  7. Have a preplanned overnight hospitalization during the period of the study.
  8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example: uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
  9. Have presence of corneal subepithelial infiltrates at Visit 1.
  10. Have active or history of ocular herpes.

  11. Have at enrollment or within \<= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-adenoviral ocular infection (example: bacterial, fungal, acanthamoebal, or other parasitic).

    Note: History or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.

  12. Neonates or infants (that is (ie,) participants \< 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
  13. Neonates or infants (ie, participants \< 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
  14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
  15. Presence of any significant ophthalmic condition (example: retinopathy of prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
  16. Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma, or be a glaucoma suspect.
  17. Have any known clinically significant optic nerve defects.
  18. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
  19. Presence of significant, active condition in the posterior segment which requires invasive treatment (example: intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
  20. Have used any topical ocular or systemic anti-virals or antibiotics within \<= 7 days of enrollment.
  21. Have used any topical ocular NSAIDs within \<= 1 day of enrollment.
  22. Have used any topical ophthalmic steroids in the last \<= 14 days.
  23. Have used any systemic corticosteroid agents within \<= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area.
  24. Have used non-corticosteroid immunosuppressive agents within \<= 14 days of Day 1.
  25. Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
  26. Have any significant ocular disease (example: Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (example: cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per investigator's discretion.
  27. Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
  28. Within 30 days prior to the first dose of investigational product: Have used an investigational product or device, or Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
05

Study design

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

Study arms

  • Experimental
    SHP640

    Participants instructed to 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) (with a minimum of 2 hours between doses) for 7 days.

    Drug: SHP640

  • Placebo comparator
    Placebo

    Participants instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

    Drug: Placebo

Interventions

  • DrugSHP640

    Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.

  • DrugPlacebo

    Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Clinical Resolution 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. 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). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.

    Time frame: Day 6

Secondary outcomes

  1. Percentage of Participants With Adenoviral Eradication on Day 6

    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The 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, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.

    Time frame: Day 6

  2. Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8

    Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

    Time frame: Day 6 and 8

  3. Percentage of Participants With Adenoviral Eradication on Day 3, 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 participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.

    Time frame: Day 3, 8 and 12/ET

  4. Percentage of Participants With Clinical Resolution 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. 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). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.

    Time frame: Day 3, 8 and 12/ET

  5. Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)

    Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. 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 represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

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

  6. Number of Participants With 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 in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

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

  7. Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)

    Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

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

  8. Percentage of Participants With Expanded Clinical Resolution at 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 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

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

  9. Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)

    Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.

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

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

    Time to clinical resolution was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

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

  11. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.

    Time frame: From start of study drug administration up to Day 13

07

Results

Posted May 29, 2020
Limitations and caveats
The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety.

Participant flow

The study was conducted at 30 centers in the United States and Puerto Rico between 28 March 2017 (first participant first visit) and 16 May 2019 (last participant last visit).

Participant flow — Overall Study
MilestoneSHP640Placebo
Started7977
Completed6866
Not completed1111
Withdrew: Adverse event83
Withdrew: Protocol deviation10
Withdrew: Withdrawal by subject26
Withdrew: Lost to follow-up01
Withdrew: Lack of efficacy01

Outcome measures

PrimaryPercentage of Participants With Clinical Resolution 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. 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). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.

Time frame:
Day 6
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinical Resolution on Day 6
Percentage of participantsSHP640Placebo
Percentage of Participants With Clinical Resolution on Day 611.120.0
SecondaryPercentage of Participants With Adenoviral Eradication on Day 6

Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The 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, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.

Time frame:
Day 6
Reported as:
Number · Percentage of participants
Percentage of Participants With Adenoviral Eradication on Day 6
Percentage of participantsSHP640Placebo
Percentage of Participants With Adenoviral Eradication on Day 633.370.0
SecondaryAbsolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8

Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.

Time frame:
Day 6 and 8

No measurements were reported for this outcome.

SecondaryPercentage of Participants With Adenoviral Eradication on Day 3, 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 participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.

Time frame:
Day 3, 8 and 12/ET
Reported as:
Number · Percentage of participants
Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)
Percentage of participantsSHP640Placebo
Day 311.116.7
Day 871.466.7
Day 12/ET77.8100
SecondaryPercentage of Participants With Clinical Resolution 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. 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). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.

Time frame:
Day 3, 8 and 12/ET
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)
Percentage of participantsSHP640Placebo
Day 311.10
Day 814.344.4
Day 12/ET33.350.0
SecondaryNumber of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)

Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. 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 represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, 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 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 in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, 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.

SecondaryPercentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)

Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, 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.

SecondaryPercentage of Participants With Expanded Clinical Resolution at 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 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, 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.

SecondaryPercentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)

Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.

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 was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, 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 Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.

Time frame:
From start of study drug administration up to Day 13
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsSHP640Placebo
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)2817

Adverse events

Collected over From start of study drug administration up to Day 13. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SHP6400/79 (0%)0/79 (0%)20/79 (25.3%)
Placebo0/77 (0%)0/77 (0%)8/77 (10.4%)
Most frequent other events
Most frequent other events
EventSHP640Placebo
Dry eyeEye disorders6/792/77
Instillation site painGeneral disorders6/793/77
ConjunctivitisInfections and infestations5/791/77
Corneal infiltratesEye disorders2/792/77
Erythema of eyelidEye disorders0/792/77
Conjunctivitis allergicEye disorders2/790/77

Baseline characteristics

Intent-to-treat (ITT) population consisted of all screened participants who were randomized.

Age, Continuous
Age, Continuous(Years)SHP640PlaceboTotal
Mean42.4 ± 21.5741.3 ± 21.2141.9 ± 21.33
Sex: Female, Male
Sex: Female, Male(Participants)SHP640PlaceboTotal
Female4753100
Male322456
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SHP640PlaceboTotal
Hispanic or Latino101929
Not Hispanic or Latino6858126
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SHP640PlaceboTotal
American Indian or Alaska Native011
Asian404
Native Hawaiian or Other Pacific Islander000
Black or African American10818
White6468132
More than one race000
Unknown or Not Reported101
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Study locations

31 sites
  • Lugene Eye Institute Inc
    Glendale, California 91204, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Wolstan and Goldberg Eye Associates
    Torrance, California 90505, United States
  • Danbury Eye Physicians and Surgeons
    Danbury, Connecticut 06810, United States
  • Bruce A. Segal, MD, PA
    Delray Beach, Florida 33484, United States
  • Bowden Eye & Associates
    Jacksonville, Florida 32256, United States
  • Shettle Eye Research, Inc.
    Largo, Florida 33773, United States
  • South Florida Research Center Inc.
    Miami, Florida 33135, United States
  • International Research Center
    Tampa, Florida 33603, United States
  • Saltzer Medical Group
    Nampa, Idaho 83686, United States
  • Sabates Eye Centers
    Leawood, Kansas 40004, United States
  • Physicians to Children & Adolescents
    Bardstown, Kentucky 40004, United States
  • The Eye Care Institute
    Louisville, Kentucky 40206, United States
  • Shire Call Center
    Lexington, Massachusetts 02421, United States
  • Silverstein Eye Centers
    Kansas City, Missouri 64133, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Tekwani Vision Center
    Saint Louis, Missouri 63128, United States
  • Wellish Vision Institute
    Las Vegas, Nevada 89119, United States
  • Fichte, Endl and Elmer Eyecare
    Niagara Falls, New York 14304, United States
  • Apex Eye Kenwood
    Cincinnati, Ohio 45236, United States
  • Cleveland Eye Clinic
    Cleveland, Ohio 44141, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • IPS Research Company
    Oklahoma City, Oklahoma 73120, United States
  • Eyeland Vision
    El Paso, Texas 79934, United States
  • Houston Eye Associates
    Houston, Texas 77025, United States
  • Sun Research Institute, LLC
    San Antonio, Texas 78215, United States
  • Chrysalis Clinical Research
    Saint George, Utah 84790, United States
  • Jean Brown Research
    Salt Lake City, Utah 84117, United States
  • Piedmont Eye Center, Inc.
    Lynchburg, Virginia 24502, United States
  • Emanuelli Research & Development Center, LLC
    Arecibo, 00613, Puerto Rico
  • University Of Puerto Rico, School of Medicine
    Carolina, 00984, Puerto Rico
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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
  • Study protocol · May 31, 2018
  • 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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02998554
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Dec 20, 2016
Start date
Mar 28, 2017
Primary completion
May 16, 2019
Completion
May 16, 2019
Results posted
May 29, 2020
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
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Not currently enrolling

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

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Discussion

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