Trials / Completed
CompletedNCT05023304
In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Vance Thompson Vision · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dextenza 0.4Mg Ophthalmic Insert | The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration. |
| DRUG | Topical prednisolone acetate | Standard of care topical drop regimen with four week taper |
Timeline
- Start date
- 2021-08-23
- Primary completion
- 2022-07-27
- Completion
- 2022-10-01
- First posted
- 2021-08-26
- Last updated
- 2025-08-17
- Results posted
- 2025-08-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05023304. Inclusion in this directory is not an endorsement.