Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo (NCT02998554) | Clinical Trial Compass
TerminatedPhase 3
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo
Stopped: Sponsor decision, unrelated to safety
United States156 participantsStarted 2017-03-28
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
✓. Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally-authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
✓. Participants of any age at Visit 1 (Note: Participants less than (\<) 3 months of age at Visit 1 must have been full-term, that is 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 (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.
✓. 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.
✓. 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 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.
What they're measuring
1
Percentage of Participants With Clinical Resolution on Day 6
✓. 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
✕. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
✕. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
✕. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
✕. Prior enrollment in a FST-100 or SHP640 clinical study.
✕. Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
✕. Have a history of ocular surgical intervention within \<= 6 months prior to Visit 1 or planned for the period of the study.
✕. Have a preplanned overnight hospitalization during the period of the study.
✕. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example: uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.