PREFERENTIAL Study

Duke University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Cataract Surgery; Glaucoma Surgery

Treatments: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04563559

Pro00104649

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

DEXTENZA vs prednisolone acetate 1%)

Other group

Description:

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.

Treatment:

Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Drug: Dextenza 0.4Mg Ophthalmic Insert