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

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ClinicalTrials.gov Identifier: NCT02998541
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis.

Condition or disease Intervention/treatment Phase
Adenoviral Conjunctivitis Drug: SHP640 Drug: PVP-I 0.6% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 930 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: SHP640
Instill 1 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
Instill 1 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.

Active Comparator: PVP-I 0.6%
Instill 1 drop of PVP-I ophthalmic solution in each eye QID for 7 days.
Drug: PVP-I 0.6%
Instill 1 drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

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




Primary Outcome Measures :
  1. Clinical Resolution Status Between SHP640 and Placebo as Measured by Absence of Bulbar Conjunctival Injection [ Time Frame: Day 6 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.

  2. Clinical Resolution Status Between SHP640 and Placebo as Measured by Watery Conjunctival Discharge [ Time Frame: Day 6 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.


Secondary Outcome Measures :
  1. Clinical Resolution Between SHP640 and Povidone-Iodine (PVP-I) as Measured by Absence of Bulbar Conjunctival Injection [ Time Frame: Day 6 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.

  2. Adenoviral Eradication Between PVP-I and Placebo as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 3 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  3. Adenoviral Eradication Between SHP640 and Placebo as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 6 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  4. Adenoviral Eradication Between SHP640 and PVP-I as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 6 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  5. Clinical Resolution Between PVP-I and Placebo as Measured by Absence of Bulbar Conjunctival Injection [ Time Frame: Day 6 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.

  6. Adenovirus Viral Titer Assessed by Quantitative Polymerase Chain Reaction (qPCR) [ Time Frame: Day 6 and Day 8 ]
    qPCR test will be performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  7. Adenoviral Eradication as Assessed by Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 8 and Day 12 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  8. Clinical Resolution of Adenoviral Conjunctivitis [ Time Frame: Day 3, Day 8 and Day 12 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.

  9. Individual Clinical Signs [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Individual Clinical Signs for bulbar conjunctival injection and watery conjunctival discharge will be assessed in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  10. Global Clinical Score [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Global clinical score is the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  11. Change From Baseline in The Global Clinical Score [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Global clinical score is the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  12. Modified Clinical Resolution [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Modified clinical resolution is defined as a global clinical score of 0 or 1 in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  13. Expanded Clinical Resolution [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Expanded clinical resolution is 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. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  14. Time to Clinical Resolution [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Time to clinical resolution based upon assessments will be analysed in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.

  15. Status of Cross-over Infection [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    The status of cross-over infection which is assessed by CC-IFA to a subject's fellow eye will be for subjects with only 1 infected eye at baseline.

  16. Safety and Tolerability of SHP640 as compared to PVP-I and Placebo [ Time Frame: Day 1 up to Day 13 ]
    Safety and tolerability of SHP640, compared to PVP-I and placebo will be evaluated in the treatment of subjects with adenoviral conjunctivitis.

  17. Clinical Resolution Between SHP640 and Povidone-Iodine (PVP-I) as Measured by Watery Conjunctival Discharge [ Time Frame: Day 6 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.

  18. Clinical Resolution Between PVP-I and Placebo as Measured by Watery Conjunctival Discharge [ Time Frame: Day 6 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects of any age at Visit 1.
  2. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
  3. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye.
  4. Be willing to discontinue contact lens wear for the duration of the study.
  5. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
  6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  1. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  2. Prior enrollment in a FST100 or SHP640 clinical study.
  3. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  4. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
  5. Have a preplanned overnight hospitalization during the period of the study.
  6. Have active or history of ocular herpes.
  7. 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 (eg, bacterial, fungal, acanthamoebal, or other parasitic).
  8. Other protocol defined exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998541


Contacts
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Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@Shire.com

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Sponsors and Collaborators
Shire
Investigators
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Study Director: Shire Physician Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02998541     History of Changes
Other Study ID Numbers: SHP640-301
2016-002439-14 ( EudraCT Number )
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Pharmaceutical Solutions
Dexamethasone
Dexamethasone acetate
BB 1101
Ophthalmic Solutions
Povidone-Iodine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors