A Phase 2/3 interventional study of Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] in Cataract Surgery and Glaucoma Surgery, sponsored by Duke University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by Duke University · Phase 2/3, Interventional, and Treatment
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.
Eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively.
Males and Females 18 years and older with 1)Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole corrected distance visual acuity (CDVA) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber Intraocular Len (IOL) combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes.
Study visits will consist of eye exam with ocular photos from an Optical Coherence Tomography (OCT).
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Exclusion Criteria:
Systemic NSAID use
o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days
Subjects will randomly receive Dextenza or prednisolone acetate 1% in the first eye after surgery. At the time of the second eye surgery, the other eye will receive the drug that the first eye did not receive. Subjects will receive both drugs during the course of the study and therefore there is only 1 ARM for this study.
Drug: Dextenza 0.4Mg Ophthalmic Insert · Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule
Percent of patients who stated they preferred dexamethasone insert as measured by patient report
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
Time frame: 45 days post second surgery
Percent of patients who stated they preferred topical prednisolone insert as measured by patient report
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
Time frame: 45 days post second surgery
The incidence of AE
The incidence of adverse events
Time frame: Up to 3 months
The severity of AE
The severity of adverse events
Time frame: Up to 3 months
Resolution of inflammation
Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion.
Time frame: Day 14 post surgery
Resolution of pain
Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7
Time frame: Day 7 post surgery
Absence of cell flare at day 14
Absence of cell flare at day 14
Time frame: Day 14 post surgery
Mean change in BCVA
Mean change in BCVA
Time frame: Baseline, 3 months
Mean change in central retinal thickness as measured by OCT
Mean change in central retinal thickness as measured by OCT
Time frame: Baseline, 3 months
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
Time frame: 28 days post surgery
Percent of patients with rebound inflammation
Percent of patients with rebound inflammation
Time frame: Up to 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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