A Phase 2, randomized, double-masked, placebo-controlled, parallel-assignment study of topical N-Chlorotaurine (NCT) formulated with ammonium chloride administered for 10 days in patients with epidemic adenoviral keratoconjunctivitis (EKC)

• Conditions: Epidemic adenoviral keratoconjunctivitis (EKC); MedDRA version: 14.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10001257Term: Adenoviral conjunctivitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10023348Term: KeratoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2007-002101-50-AT
• Lead Sponsor: Acuity Pharmaceuticals, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-19
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified