PREFERENTIAL Study

Phase 2

Withdrawn

• Conditions: Cataract Surgery; Glaucoma Surgery
• Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

• Registration Number: NCT04563559
• Lead Sponsor: Duke University

Brief Summary

To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-24
• Study Start: 2020-11
• Status Verified: 2021-11
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEXTENZA vs prednisolone acetate 1%)	Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]	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.
DEXTENZA vs prednisolone acetate 1%)	Dextenza 0.4Mg Ophthalmic Insert	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.

Primary Outcome Measures

Name	Time	Method
Percent of patients who stated they preferred topical prednisolone insert as measured by patient report	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.
Percent of patients who stated they preferred dexamethasone insert as measured by patient report	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of AE	Up to 3 months	The incidence of adverse events
Absence of cell flare at day 14	Day 14 post surgery	Absence of cell flare at day 14
Resolution of inflammation	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.
Percent of patients with rebound inflammation	Up to 3 months	Percent of patients with rebound inflammation
Resolution of pain	Day 7 post surgery	Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7
The severity of AE	Up to 3 months	The severity of adverse events
Mean change in BCVA	Baseline, 3 months	Mean change in BCVA
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery	28 days post surgery	Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
Mean change in central retinal thickness as measured by OCT	Baseline, 3 months	Mean change in central retinal thickness as measured by OCT