| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| E.1.1.1 | Medical condition in easily understood language | |
| E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 | | E.1.2 | Level | PT | | E.1.2 | Classification code | 10061784 | | E.1.2 | Term | Conjunctivitis bacterial | | E.1.2 | System Organ Class | 10021881 - Infections and infestations | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | | The primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5). | |
| E.2.2 | Secondary objectives of the trial | | The key secondary objective of this study is to evaluate the efficacy of SHP640 based on bacterial eradication (defined as absence of all bacterial species present at or above pathological threshold at baseline) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5). | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | Main Inclusion Criteria:
3. Subjects of any age at Visit 1 (Note: subjects <3 months of age at Visit 1 must have been full-term, ie ≥37 weeks gestational age at birth).
4. Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
5. Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
5.1. Report presence of signs and/or symptoms of bacterial conjunctivitis for ≤4 days prior to Visit 1
5.2. Bulbar conjunctival injection: a grade of ≥1 on 0-4 scale of Bulbar Conjunctival Injection Scale
5.3. Ocular conjunctival discharge: a grade of ≥1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale
6. Be willing to discontinue contact lens wear for the duration of the study.
Full list of Inclusion criteria can be found in the protocol. | |
| E.4 | Principal exclusion criteria | Main 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 subject 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.
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 (eg, uveitis, iritis, ulcerative keratitis, chronic
blepharoconjunctivitis), other than bacterial conjunctivitis.
9. Have active or a history of ocular herpes.
10. Have at enrollment or within ≤30 days of Visit 1, a clinical
presentation more consistent with the diagnosis of non-infectious
conjunctivitis (except presumed seasonal/perennial allergic
conjunctivitis), or non-bacterial ocular infection (eg, viral, fungal,
acanthamoebal, or other parasitic). Note: history or concomitant
presence of presumed seasonal or perennial allergic conjunctivitis
signs/symptoms is not exclusionary.
11. Neonates or infants (ie. subjects 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.
12. Neonates or infants (ie. subjects 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.
13. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
14. Presence of any significant ophthalmic condition (eg, Retinopathy of
Prematurity, congenital cataract, congenital glaucoma) or other
congenital disorder with ophthalmic involvement that could affect study
variables.
15. Be a known intraocular pressure (IOP) steroid responder, have a
known history of glaucoma, be a glaucoma suspect.
16. Have any known clinically significant optic nerve defects.
17. 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.
18. Presence of significant, active condition in the posterior segment
that requires invasive treatment (eg, intravitreal treatment with
vascular endothelial growth factor inhibitors or corticosteroids) and may
progress during the study participation period.
Full list of Exclusion criteria can be found in the protocol. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | Clinical resolution status (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) in the study eye at Visit 3 (Day 5) between SHP640 and placebo. | |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | |
| E.5.2 | Secondary end point(s) | Key Secondary Efficacy Endpoints:
1.Bacterial eradication status (defined as absence of all bacterial species present at or above pathological threshold at baseline) in the study eye at Visit 3 (Day 5) between SHP640 and placebo.
Secondary Efficacy Endpoints:
2. Clinical resolution status of bacterial conjunctivitis at Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) in the study eye
3. Bacterial eradication status (defined as absence of all bacterial species present at or above pathological threshold at baseline) as assessed by bacterial culture at Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) in the study eye
4. Absolute and change from baseline of the individual clinical signs (bulbar conjunctival injection and ocular conjunctival discharge) at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
5.The global clinical score (defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge) and change from baseline in the global clinical score at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
6. Modified clinical resolution status, defined as a global clinical score of 0 or 1, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
7. Expanded clinical resolution status, defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
8. Time to clinical resolution based upon assessments at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
9. Use of rescue medication
Safety Endpoints:
- BCVA
- Slit lamp biomicroscopy
- Non-dilated/dilated fundus examination
- Urine pregnancy testing
- Adverse events | |
| E.5.2.1 | Timepoint(s) of evaluation of this end point | 1.Visit 3 (Day 5)
2. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12)
3. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12)
4. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
5. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
6. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
7. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
8. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
9. throughout the study duration
Safety Endpoints: throughout the study duration | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description | |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 | The trial involves single site in the Member State concerned | No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 56 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | | Australia | | Austria | | Canada | | Colombia | | Estonia | | France | | Germany | | Hungary | | India | | Israel | | Italy | | Peru | | Philippines | | Poland | | South Africa | | Spain | | United Kingdom | | United States | |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
