Epidemic adenoviral keratoconjunctivitis (EKC) MedDRA version: 14.1 Level: LLT Classification code 10014975 Term: Epidemic keratoconjunctivitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10001257 Term: Adenoviral conjunctivitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10023348 Term: Keratoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: NCT with ammonium chloride
Pharmaceutical Form: Eye drops
INN or Proposed INN: N-Chlorotaurine
CAS Number: 51036-13-6
Current Sponsor code: NCT
Concentration unit: % (W/V) percent weight
Sponsors
Acuity Pharmaceuticals, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
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 ß-HCG serum test 7. Patient is considered able to complete a drug administration record for the 10 day dosing period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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.;Timepoint(s) of evaluation of this end point: day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: days 0, 4, 10, 20, 30, and 60 | — |
Countries
Austria
Outcome results
None listed