Recruiting

Dextenza

Sponsor:

Kerry Assil, MD

Code:

NCT04592081

Conditions

Post-Surgical Ocular Pain

Post-Surgical Ocular Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dextenza 0.4Mg Ophthalmic Insert

Study Details

Brief summary:

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

Conditions

Post-Surgical Ocular Pain

Post-Surgical Ocular Inflammation

Study ID

NCT04592081

Start date

Aug 1, 2020

Status verified date

Oct, 2020

Completion date

Mar 11, 2021

Anticipated

Primary completion date

Feb 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DEXTENZA placed within the upper canaliculus

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

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.

Interventions

Dextenza 0.4Mg Ophthalmic Insert

Dextenza 0.4Mg Ophthalmic Insert

Primary outcome measure

  • Post-operative inflammation scores [ Time Frame: Assessed on Days 1, 7, 30 for change ]
  • Post-op pain scores [ Time Frame: Assessed on Days 1, 7, 30 for change ]

Central Contacts and Locations

Central contacts

Kellie Burch

310-651-2392kburch@assileye.com

Locations

Assil Eye Institute

Recruiting

Beverly Hills, California, United States, 90210

Principal Investigator:

Kerry Assil, MD

More Information

Sponsor

Kerry Assil, MD

Last update posted

Oct 19, 2020

Last verified

Oct, 2020

Keywords

  • Dexamethasone
  • Cataract
  • Capsule Opacification
  • Inflammation
  • Lens Diseases
  • Eye Diseases
  • Anti-Inflammatory Agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kerry Assil, MD on 2020-10-19.