PREFERENTIAL Study

Cataract Surgery Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04563559
• Other study ID #: Pro00104649
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: November 2020
• Est. completion date: November 2021

Study information

• Verified date: November 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Glaucoma
• Glaucoma Surgery

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Ocular Therapeutix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 days post second surgery
Primary	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.	45 days post second surgery
Secondary	The incidence of AE	The incidence of adverse events	Up to 3 months
Secondary	The severity of AE	The severity of adverse events	Up to 3 months
Secondary	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.	Day 14 post surgery
Secondary	Resolution of pain	Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7	Day 7 post surgery
Secondary	Absence of cell flare at day 14	Absence of cell flare at day 14	Day 14 post surgery
Secondary	Mean change in BCVA	Mean change in BCVA	Baseline, 3 months
Secondary	Mean change in central retinal thickness as measured by OCT	Mean change in central retinal thickness as measured by OCT	Baseline, 3 months
Secondary	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	28 days post surgery
Secondary	Percent of patients with rebound inflammation	Percent of patients with rebound inflammation	Up to 3 months