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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04563559
Other study ID # Pro00104649
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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