Acute Infectious Keratoconjunctivitis
Conditions
Keywords
pink eye, conjunctivitis
Brief summary
Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.
Interventions
DRUGINV-102
INV-102 Ophthalmic Solution
DRUGVehicle
Vehicle Ophthalmic Solution
Sponsors
Invirsa, Inc.
Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 allergic conjunctivitis as a primary cause of conjunctival hyperemia (bulbar redness) and/or discharge in the opinion of the Investigator * Suspected corneal ulcer * Ocular topical steroid use within two weeks prior to baseline visit * Ocular topical antibiotic use for less than 24 hours or greater than 96 hours of dosing prior to Baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics) * Ocular topical povidone iodine use within 1 week prior to baseline visit * Systemic antibiotic use within 2 weeks prior to baseline visit * Ocular topical or systemic anti-fungal within 2 weeks prior to baseline visit * Ocular topical or systemic anti-viral use within 2 weeks prior to baseline visit * Corticosteroid (including but not limited to oral, intranasal, inhaled, topical, etc.) or any immunosuppressant use 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 or ocular microsporidia infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Change in Combined Clinical Score | Through End of Treatment (Day 8) | To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Percent of participants requiring rescue | Day 3 | To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control |
Countries
Thailand, United States
Outcome results
None listed