Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery

VivaVision Biotech

Status and phase: Completed; Phase 2

Conditions: Inflammation

Treatments: Drug: VVN461 Ophthalmic Solution 1.0%; Drug: VVN461 Ophthalmic Solution 0.5%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT06164743

VVN461-CS-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups, including a placebo group

VVN461 1.0%

Experimental group

Description:

VVN461 Ophthalmic Solution, 1.0%

Treatment:

Drug: VVN461 Ophthalmic Solution 1.0%

VVN461 0.5%

Experimental group

Description:

VVN461 Ophthalmic Solution, 0.5%

Treatment:

Drug: VVN461 Ophthalmic Solution 0.5%

Vehicle

Placebo Comparator group

Description:

VVN461 Vehicle

Treatment:

Drug: Vehicle