Back to resultsDextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
Primary Purpose
Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Sponsored by
About this trial
This is an interventional treatment trial for Post-Surgical Ocular Pain focused on measuring Dexamethasone, Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases, Anti-Inflammatory Agents
Eligibility Criteria
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
Sites / Locations
- Assil Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DEXTENZA placed within the upper canaliculus
DEXTENZA placed within the lower canaliculus
Arm Description
Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Outcomes
Primary Outcome Measures
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.
Post-op pain scores
As measured on a scale from 0-10
Secondary Outcome Measures
Ease of Insertion (successful implantation)
As measured by Physician Ease of Use Questionnaire
Intraocular Pressure
As measured by Goldmann Applanation
Visual Outcome
As measured by BCVA
Absence of CME
As measured by OCT
Need of additional steroids
As measured by rescue medication added
Absence of rebound iritis
As measured by presence of cells
Patient reported outcomes
As measured by patient questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04592081
Brief Title
Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
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).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
March 11, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kerry Assil, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
Keywords
Dexamethasone, Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases, Anti-Inflammatory Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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/PCIOL
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEXTENZA placed within the upper canaliculus
Arm Type
Experimental
Arm Description
Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Arm Title
DEXTENZA placed within the lower canaliculus
Arm Type
Active Comparator
Arm Description
Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Ophthalmic Insert
Intervention Description
Dextenza 0.4Mg Ophthalmic Insert
Primary Outcome Measure Information:
Title
Post-operative inflammation scores
Description
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.
Time Frame
Assessed on Days 1, 7, 30 for change
Title
Post-op pain scores
Description
As measured on a scale from 0-10
Time Frame
Assessed on Days 1, 7, 30 for change
Secondary Outcome Measure Information:
Title
Ease of Insertion (successful implantation)
Description
As measured by Physician Ease of Use Questionnaire
Time Frame
Assessed on Day 0 (Day of Insertion)
Title
Intraocular Pressure
Description
As measured by Goldmann Applanation
Time Frame
Assessed on Days 1, 7, 30, 90 for change
Title
Visual Outcome
Description
As measured by BCVA
Time Frame
Assessed at all time points;comparison of Day 30 vs Day 90
Title
Absence of CME
Description
As measured by OCT
Time Frame
Assessed on Day -30 to -1 and Day 90 for change
Title
Need of additional steroids
Description
As measured by rescue medication added
Time Frame
Assessed on Days 1, 7, 30, 90 for change
Title
Absence of rebound iritis
Description
As measured by presence of cells
Time Frame
Assessed on Days 1, 7, 30, 90 for change
Title
Patient reported outcomes
Description
As measured by patient questionnaire
Time Frame
Assessed on Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kellie Burch
Phone
310-651-2392
Email
kburch@assileye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Assil, MD
Organizational Affiliation
Assil Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assil Eye Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Harris
First Name & Middle Initial & Last Name & Degree
Kerry Assil, MD
12. IPD Sharing Statement
Learn more about this trial
Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
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