PREFERENTIAL Study
NCT04563559 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL
Last updated 2021-11-17
Summary
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.
Conditions
- Cataract Surgery
- Glaucoma Surgery
Interventions
- DRUG
-
Dextenza 0.4Mg Ophthalmic Insert
The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
- DRUG
-
Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule
Sponsors & Collaborators
-
Ocular Therapeutix, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Leon Herndon, MD · Duke Eye Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-30
- Primary Completion
- 2021-11-30
- Completion
- 2021-11-30
- FDA Drug
- Yes
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