Clinical trial NCT06164743: Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
Official title: A Phase 2, Double-masked, Randomized, Vehicle-controlled Study of VVN461 Ophthalmic Solution in Treating Post -Operative Ocular Inflammation in Subjects Undergoing Routine Unilateral Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Lead sponsor: VivaVision Biotech, Inc
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 91
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked, parallel, randomized
Primary purpose: TREATMENT

Brief summary: This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification

Detailed description: This is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the US assessing the safety and ocular efficacy of VVN461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral CELR surgery via phacoemulsification without surgical complication. Approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. Subjects will administer 1 eye drop in the study eye four times a day (QID) for 14 days.

Eligibility criteria: Inclusion Criteria:

* ≥21 years of age and in good general health at Visit 1 (Screening)
* Willing and able to provide informed consent and provide relevant privacy authorization(s)
* Willing and able to comply with study requirements and visit schedule
* Clear ocular media (other than cataract) in the study eye
* Planning to undergo routine unilateral cataract surgery via phacoemulsification extraction and implantation of an intraocular lens.

Exclusion Criteria:

* Any ocular pain at Visit 1 (Screening)
* Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs

Primary outcomes:
measure: Anterior Chamber Cell: Categorical Cure
timeFrame: Day 14
Secondary outcomes:
measure: Safety of VVN461
timeFrame: Day 21
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Associates
state: California
city: Grand Junction
country: United States
facility: ICON Eye Care
state: Colorado
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd
state: Missouri
city: Las Vegas
country: United States
facility: Center For Sight - Las Vegas
state: Nevada
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
Study officials:
References: