Trials / Completed
CompletedNCT03192150
2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
A Phase 3, Randomized, Multicenter, Double-masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-305 (0.1% Dexamethasone in DuraSite® 2) to DuraSite 2 Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 246 (actual)
- Sponsor
- Sun Pharmaceutical Industries Limited · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation and pain associated with cataract surgery.
Detailed description
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISV-305 | Dexamethasone in DuraSite® 2 twice daily for 16 days |
| OTHER | Vehicle | Vehicle twice daily for 16 days |
Timeline
- Start date
- 2018-01-03
- Primary completion
- 2019-11-18
- Completion
- 2019-11-18
- First posted
- 2017-06-19
- Last updated
- 2021-11-19
- Results posted
- 2021-01-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03192150. Inclusion in this directory is not an endorsement.