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
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| ISV-303 BID | Experimental | Drug: ISV-303 | |
| ISV-303 QD | Experimental | Drug: ISV-303 | |
| Xibrom BID | Active comparator | Drug: Xibrom™ | |
| DuraSite Vehicle BID | Placebo comparator | Drug: DuraSite Vehicle | |
- ISV-303 (Drug): 0.075% of bromfenac in DuraSite dosed QD
- ISV-303 (Drug): 0.075% of bromfenac in DuraSite dosed BID
- DuraSite Vehicle (Drug): Vehicle dosed BID
- Xibrom™ (Drug): 0.09% bromfenac dosed BID
+Outcome measures
Primary outcomes
- Ocular Inflammation [15 days]: 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* 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
* Additional inclusion criteria also apply
Exclusion Criteria:
* 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
* Additional exclusion criteria also apply
+Posted results
Participant flow
| Milestone | ISV-303 BID | ISV-303 QD | Xibrom BID | DuraSite Vehicle BID |
|---|
| Started | 40 | 45 | 42 | 42 |
| Completed | 37 | 42 | 37 | 22 |
| Not completed | 3 | 3 | 5 | 20 |
Outcome results
- Ocular Inflammation (Primary), Number, participants: ISV-303 BID 21; ISV-303 QD 24; Xibrom BID 18; DuraSite Vehicle BID 8
Adverse events
Time frame: 29 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| ISV-303 BID | 0 | 1/40 (2.5%) | 0/40 (0.0%) |
| ISV-303 QD | 0 | 0/45 (0.0%) | 4/45 (8.9%) |
| Xibrom BID | 0 | 1/42 (2.4%) | 1/42 (2.4%) |
| DuraSite Vehicle BID | 0 | 0/42 (0.0%) | 1/42 (2.4%) |
Serious adverse events by term
| Term | Organ system | ISV-303 BID | ISV-303 QD | Xibrom BID | DuraSite Vehicle BID |
|---|
| Faecaloma | Gastrointestinal disorders | 1/40 | 0/45 | 0/42 | 0/42 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 0/40 | 0/45 | 1/42 | 0/42 |
Other adverse events by term
| Term | Organ system | ISV-303 BID | ISV-303 QD | Xibrom BID | DuraSite Vehicle BID |
|---|
| Iritis | Eye disorders | 0/40 | 4/45 | 1/42 | 1/42 |
+Publications
- Results publication: 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 28819932