Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

Sponsor

Kerry Assil, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04592081

Collaborator

(none)

Enrollment

Location

Arms

7.3

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

Condition or Disease	Intervention/Treatment	Phase
Post-Surgical Ocular Pain Post-Surgical Ocular Inflammation	Drug: Dextenza 0.4Mg Ophthalmic Insert	Phase 4

Detailed Description

Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All patients will receive: First eye randomized for either lower lid (control eye) or upper lid (study eye) insertion and the contralateral eye receiving the opposite site insertion in the OR following CE/PCIOLAll patients will receive: First eye randomized for either lower lid (control eye) or upper lid (study eye) insertion and the contralateral eye receiving the opposite site insertion in the OR following CE/PCIOL

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Clinical Trial aSsessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert When Placed Within the Upper Eye Lid Canaliculus in Comparison to the Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With Posterior Chamber Intraocular Lens Implant (CE/PCIOL).

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Mar 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DEXTENZA placed within the upper canaliculus Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.	Drug: Dextenza 0.4Mg Ophthalmic Insert Dextenza 0.4Mg Ophthalmic Insert
Active Comparator: DEXTENZA placed within the lower canaliculus Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.	Drug: Dextenza 0.4Mg Ophthalmic Insert Dextenza 0.4Mg Ophthalmic Insert

Arm

Intervention/Treatment

Experimental: DEXTENZA placed within the upper canaliculus

Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Dextenza 0.4Mg Ophthalmic Insert

Active Comparator: DEXTENZA placed within the lower canaliculus

Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Dextenza 0.4Mg Ophthalmic Insert

Outcome Measures

Primary Outcome Measures

Post-operative inflammation scores [Assessed on Days 1, 7, 30 for change]
As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1.
Post-op pain scores [Assessed on Days 1, 7, 30 for change]
As measured on a scale from 0-10

Secondary Outcome Measures

Ease of Insertion (successful implantation) [Assessed on Day 0 (Day of Insertion)]
As measured by Physician Ease of Use Questionnaire
Intraocular Pressure [Assessed on Days 1, 7, 30, 90 for change]
As measured by Goldmann Applanation
Visual Outcome [Assessed at all time points;comparison of Day 30 vs Day 90]
As measured by BCVA
Absence of CME [Assessed on Day -30 to -1 and Day 90 for change]
As measured by OCT
Need of additional steroids [Assessed on Days 1, 7, 30, 90 for change]
As measured by rescue medication added
Absence of rebound iritis [Assessed on Days 1, 7, 30, 90 for change]
As measured by presence of cells
Patient reported outcomes [Assessed on Day 90]
As measured by patient questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
Bilateral cataract surgery with IOL has been planned
Willing and able to comply with clinic visits and study related procedures
Willing and able to sign the informed consent form

Exclusion Criteria:

Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
Active infectious systemic disease
Active infectious ocular or extraocular disease
Obstructed nasolacrimal duct in the study eye(s)
Hypersensitivity to dexamethasone
Patients being treated with immunomodulating agents in the study eye(s)
History of prior ocular surgery, excluding Lasik or PRK
History of ocular inflammation or macular edema
Use of any systemic NSAIDs greater than 375 mg per day
Patients being treated with immunosuppressants and/or oral steroids
Patients with a corticosteroid implant (i.e. Ozurdex)
Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator