Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers
1 other identifier
interventional
169
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
July 13, 2016
CompletedNovember 19, 2021
November 1, 2021
5 months
August 26, 2010
April 26, 2016
November 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Ocular Inflammation
Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.
15 days
Study Arms (4)
ISV-303 BID
EXPERIMENTALISV-303 QD
EXPERIMENTALXibrom BID
ACTIVE COMPARATORDuraSite Vehicle BID
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
- Meet the best corrected visual acuity score requirement
- Meet the IOP requirement
You may not qualify if:
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
- Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.
PMID: 28819932DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Senior Manager, Clinical Sciences
- Organization
- InSite Vision
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 30, 2010
Study Start
August 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
November 19, 2021
Results First Posted
July 13, 2016
Record last verified: 2021-11