Trials / Completed
CompletedNCT04911361
The DEPOT Study (Dry Eye Prescription Options for Therapy)
The DEPOT Study (Dry Eye Prescription Options for Therapy): A Randomized Controlled Clinical Trial Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Eyelid Canaliculus in Comparison to Topical Loteprednol Suspension for the Treatment of Episodic Dry Eye
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Research Insight LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.
Detailed description
The DEPOT Study (Dry Eye Prescription Options for Therapy): A randomized controlled clinical trial assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower eye eyelid canaliculus in comparison to topical loteprednol suspension for the treatment of episodic dry eye.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone | Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group) |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2021-12-28
- Completion
- 2021-12-28
- First posted
- 2021-06-03
- Last updated
- 2022-01-03
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04911361. Inclusion in this directory is not an endorsement.