E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epidemic adenoviral keratoconjunctivitis (EKC) |
Keratoconjunctivitis epidemica |
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E.1.1.1 | Medical condition in easily understood language |
viral inflammation of the conjunctiva |
virale Bindehautentzündung |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014975 |
E.1.2 | Term | Epidemic keratoconjunctivitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10001257 |
E.1.2 | Term | Adenoviral conjunctivitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023348 |
E.1.2 | Term | Keratoconjunctivitis |
E.1.2 | System Organ Class | 100000004853 |
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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 objective of this phase 2 randomized, double-masked, placebo-controlled, parallel assignment study is to demonstrate safety, tolerability and preliminary efficacy of 0.1% NCT + 0.1% NH4Cl for the treatment of EKC. |
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E.2.2 | Secondary objectives of the trial |
Ocular safety will be evaluated by assessing:
• Incidence of adverse events/serious adverse events
• Ophthalmic examination
Primary efficacy measure:
The proportion of patients at day 10 in each group with a negative adenoviral culture and determination by polymerase chain reaction (PCR).
Secondary efficacy measures:
The proportion of patients at day 20 in each group with a negative adenoviral culture and PCR finding.
The objective signs and symptoms scores for each group will be compared at days 10, 20, 30 and 60.
The subjective signs and symptoms scores for each group will be compared at days 10, 20, 30 and 60.
The change in objective and subjective signs and symptoms scores from baseline over time will be compared.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients must sign a written and fully informed consent for participation in the study
2. Patients of either sex aged > 18 years of age
3. Appearance and symptoms of EKC in one or both eyes
4. Positive for adenoviral antigen using the RPC rapid adenodetector test
5. Symptoms of EKC for less than 3 days
6. Females of childbearing potential will have to provide urine and serum samples for a rapid urine pregnancy test and confirmation of a negative result by β-HCG serum test
7. Patient is considered able to complete a drug administration record for the 10 day dosing period
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E.4 | Principal exclusion criteria |
1. Symptoms for EKC have been present for > 3 days
2. Conjunctivitis can be attributed to any cause other than epidemic adenovirus
3. The presence of herpetic keratitis
4. The patient is taking any other ocular medication during the study period (60 days)
5. The patient is wearing or needs to wear contact lens during the 60 day study period
6. The patient is pregnant or breast feeding
7. The patient is female and not practicing adequate contraception
8. The patient is taking any experimental medication for any reason or participating in another clinical study
9. The patient is unable to return for all study visits for the 60 day study period
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E.5 End points |
E.5.1 | Primary end point(s) |
The objective of this phase 2 randomized, double-masked, placebo-controlled, parallel assignment study is to demonstrate safety, tolerability and preliminary efficacy of 0.1% NCT + 0.1% NH4Cl for the treatment of EKC.
Primary endpoint: The proportion of subjects at 10 days in each group with a negative adenoviral culture. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The proportion of patients at 10 days in each group with a negative adenoviral PCR
The proportion of patients at day 20 in each group with a negative adenoviral culture and determination by PCR.
The objective signs and symptoms scores for each group will be compared at days 10, 20, 30 and 60.
The subjective signs and symptoms scores for each group will be compared at days 10, 20, 30 and 60.
The change in objective and subjective signs and symptoms scores from baseline over time will be compared.
The number of subepithelial infiltrates (nummuli) will be compared at days 20, 30 and 60.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
days 0, 4, 10, 20, 30, and 60 |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |