- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04563559
PREFERENTIAL Study
Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years and older
- 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 CDVA of at least 20/200 in both eyes
- 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 IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes
Exclusion Criteria:
- Active or history of chronic or recurrent inflammatory eye disease in either eye
- Ocular pain in either eye
- Proliferative diabetic retinopathy in either eye
- Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
- Laser or incisional ocular surgery during the study period and 6 months prior in either eye
- Systemic concomitant pain medication management with pharmacologic class of oxycodone
Systemic NSAID use
o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days
- Clinically significant macular edema (CSME)
- History of cystoid macular edema in the study eye
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: DEXTENZA vs prednisolone acetate 1%)
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients who stated they preferred dexamethasone insert as measured by patient report
Time Frame: 45 days post second surgery
|
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
|
45 days post second surgery
|
Percent of patients who stated they preferred topical prednisolone insert as measured by patient report
Time Frame: 45 days post second surgery
|
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
|
45 days post second surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of AE
Time Frame: Up to 3 months
|
The incidence of adverse events
|
Up to 3 months
|
The severity of AE
Time Frame: Up to 3 months
|
The severity of adverse events
|
Up to 3 months
|
Resolution of inflammation
Time Frame: Day 14 post surgery
|
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.
|
Day 14 post surgery
|
Resolution of pain
Time Frame: Day 7 post surgery
|
Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7
|
Day 7 post surgery
|
Absence of cell flare at day 14
Time Frame: Day 14 post surgery
|
Absence of cell flare at day 14
|
Day 14 post surgery
|
Mean change in BCVA
Time Frame: Baseline, 3 months
|
Mean change in BCVA
|
Baseline, 3 months
|
Mean change in central retinal thickness as measured by OCT
Time Frame: Baseline, 3 months
|
Mean change in central retinal thickness as measured by OCT
|
Baseline, 3 months
|
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
Time Frame: 28 days post surgery
|
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
|
28 days post surgery
|
Percent of patients with rebound inflammation
Time Frame: Up to 3 months
|
Percent of patients with rebound inflammation
|
Up to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leon Herndon, MD, Duke Eye Center
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Lens Diseases
- Glaucoma
- Cataract
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- Pro00104649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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