Status:
COMPLETED
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
Lead Sponsor:
VivaVision Biotech, Inc
Conditions:
Inflammation
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 extracti...
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 po...
Eligibility Criteria
Inclusion
- ≥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
- Any ocular pain at Visit 1 (Screening)
- Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06164743
Start Date
January 11 2024
End Date
May 15 2024
Last Update
June 10 2025
Active Locations (10)
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1
United Medical Research Institute
Inglewood, California, United States, 90301
2
North Bay Eye Associates
Petaluma, California, United States, 94954
3
Martel Eye Associates
Rancho Cordova, California, United States, 95670
4
ICON Eye Care
Grand Junction, Colorado, United States, 81501