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)
20
Enrollment
1
Location
2
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. 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.

  2. Post-op pain scores [Assessed on Days 1, 7, 30 for change]

    As measured on a scale from 0-10

Secondary Outcome Measures

  1. Ease of Insertion (successful implantation) [Assessed on Day 0 (Day of Insertion)]

    As measured by Physician Ease of Use Questionnaire

  2. Intraocular Pressure [Assessed on Days 1, 7, 30, 90 for change]

    As measured by Goldmann Applanation

  3. Visual Outcome [Assessed at all time points;comparison of Day 30 vs Day 90]

    As measured by BCVA

  4. Absence of CME [Assessed on Day -30 to -1 and Day 90 for change]

    As measured by OCT

  5. Need of additional steroids [Assessed on Days 1, 7, 30, 90 for change]

    As measured by rescue medication added

  6. Absence of rebound iritis [Assessed on Days 1, 7, 30, 90 for change]

    As measured by presence of cells

  7. 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:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Assil Eye InstituteBeverly HillsCaliforniaUnited States90210

Sponsors and Collaborators

  • Kerry Assil, MD

Investigators

  • Principal Investigator: Kerry Assil, MD, Assil Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kerry Assil, MD, Sponsor-Investigator, Principal Investigator, Assil Eye Institute
ClinicalTrials.gov Identifier:
NCT04592081
Other Study ID Numbers:
  • The Assil Study
First Posted:
Oct 19, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
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
Keywords provided by Kerry Assil, MD, Sponsor-Investigator, Principal Investigator, Assil Eye Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2020