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

Post-Surgical Ocular Inflammation Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592081
• Other study ID #: The Assil Study
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: March 11, 2021

Study information

• Verified date: October 2020
• Source: Assil Eye Institute
• Contact: Kellie Burch
• Phone: 310-651-2392
• Email: kburch[@]assileye.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 11, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Post-Surgical Ocular Inflammation
• Post-Surgical Ocular Pain

Intervention

Drug:
• Dextenza 0.4Mg Ophthalmic Insert
Dextenza 0.4Mg Ophthalmic Insert

Locations

Country	Name	City	State
United States	Assil Eye Institute	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Kerry Assil, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative inflammation scores	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.	Assessed on Days 1, 7, 30 for change
Primary	Post-op pain scores	As measured on a scale from 0-10	Assessed on Days 1, 7, 30 for change
Secondary	Ease of Insertion (successful implantation)	As measured by Physician Ease of Use Questionnaire	Assessed on Day 0 (Day of Insertion)
Secondary	Intraocular Pressure	As measured by Goldmann Applanation	Assessed on Days 1, 7, 30, 90 for change
Secondary	Visual Outcome	As measured by BCVA	Assessed at all time points;comparison of Day 30 vs Day 90
Secondary	Absence of CME	As measured by OCT	Assessed on Day -30 to -1 and Day 90 for change
Secondary	Need of additional steroids	As measured by rescue medication added	Assessed on Days 1, 7, 30, 90 for change
Secondary	Absence of rebound iritis	As measured by presence of cells	Assessed on Days 1, 7, 30, 90 for change
Secondary	Patient reported outcomes	As measured by patient questionnaire	Assessed on Day 90