Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis
Acute Infectious Keratoconjunctivitis
About this trial
This is an interventional treatment trial for Acute Infectious Keratoconjunctivitis focused on measuring pink eye, conjunctivitis
Eligibility Criteria
Inclusion Criteria: Male or female patient ≥ 18 years of age A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye Exclusion Criteria: Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit Infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (Note: If the blepharitis is secondary to the conjunctivitis, the patient can be included) Suspected corneal ulcer Ocular topical steroid use within two weeks prior to baseline visit Ocular topical antibiotic use for less than 24 hours of dosing prior to baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics) Ocular topical antibiotic use greater than 96 hours prior to baseline visit Ocular topical povidone iodine use within one week prior to baseline visit Systemic antibiotic use within two weeks prior to baseline visit Ocular topical or systemic anti-fungal within two weeks prior to baseline visit Ocular topical or systemic anti-viral use within two weeks prior to baseline visit Systemic steroid or any immunosuppressant within 30 days prior to baseline visit On current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included) Known or suspected ocular fungal infection Suspected ocular microsporidia infection
Sites / Locations
- King Chulalongkorn Memorial Hospital
- Mahidol university
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
INV-102 0.7% Three Times per Day (TID)
Vehicle TID
INV-102 ophthalmic solution administered for about 1 week
INV-102 ophthalmic solution administered for about 1 week