Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis

Sponsor

Invirsa, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05636228

Collaborator

Biomedical Advanced Research and Development Authority (U.S. Fed)

102

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Infectious Keratoconjunctivitis	Drug: INV-102 Drug: Vehicle	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INV-102 0.7% Three Times per Day (TID) INV-102 ophthalmic solution administered for about 1 week	Drug: INV-102 INV-102 Ophthalmic Solution
Placebo Comparator: Vehicle TID INV-102 ophthalmic solution administered for about 1 week	Drug: Vehicle Vehicle Ophthalmic Solution

Arm

Intervention/Treatment

Experimental: INV-102 0.7% Three Times per Day (TID)

INV-102 ophthalmic solution administered for about 1 week

Drug: INV-102

INV-102 Ophthalmic Solution

Placebo Comparator: Vehicle TID

INV-102 ophthalmic solution administered for about 1 week

Drug: Vehicle

Vehicle Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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