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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164743
• Other study ID #: VVN461-CS-201
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: June 2024
• Source: VivaVision Biotech, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• VVN461 Ophthalmic Solution 1.0%
Topical ocular drug
• VVN461 Ophthalmic Solution 0.5%
Topical ocular drug
• Vehicle
Topical ocular drug

Locations

Country	Name	City	State
United States	Keystone Research	Austin	Texas
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	ICON Eye Care	Grand Junction	Colorado
United States	Houston Eye Associates	Houston	Texas
United States	United Medical Research Institute	Inglewood	California
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Center For Sight - Las Vegas	Las Vegas	Nevada
United States	North Bay Eye Associates	Petaluma	California
United States	Martel Eye Associates	Rancho Cordova	California
United States	Comprehensive Eye Care, Ltd	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
VivaVision Biotech, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber cell: Categorical cure	Proportion of subjects with grade of 0	Day 14
Secondary	Safety of VVN461	Incidence of Adverse Events	Day 21