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PREFERENTIAL Study

NCT ID: NCT04563559

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-11-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Cataract Surgery Glaucoma Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type DRUG

The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Intervention Type DRUG

The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leon Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Eye Center

Other Identifiers

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Pro00104649

Identifier Type: -

Identifier Source: org_study_id