Clinical trial NCT05636228: Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis
Official title: Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Infectious Keratoconjunctivitis
Keywords: pink eye
conjunctivitis
Lead sponsor: Invirsa, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2022-12-05
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: To Evaluate the Change in Combined Clinical Score
timeFrame: Through End of Treatment (Day 8)
Secondary outcomes:
measure: To Evaluate the Percent of participants requiring rescue
timeFrame: Day 3
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Pasadena
country: United States
facility: Foothill Eye Institute
state: California
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Miami
country: United States
facility: D & H National Research Centers, INC
state: Florida
city: Miami
country: United States
facility: My Community Research Center, Inc.
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Center
state: Kansas
city: Garner
country: United States
facility: Oculos Clinical Research
state: North Carolina
city: Athens
country: United States
facility: Athens Eye Care
state: Ohio
city: Lakeway
country: United States
facility: Revolution Research/ Lake Travis Eye and Laser Center
state: Texas
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Mahidol university
Study officials:
References: