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

NCT04592081 | Unknown Phase 4 FDA Drug

• 1 other identifier: The Assil Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Post-op pain scores

  As measured on a scale from 0-10

  Assessed on Days 1, 7, 30 for change

Secondary Outcomes (7)

• Ease of Insertion (successful implantation)

  Assessed on Day 0 (Day of Insertion)

• Intraocular Pressure

  Assessed on Days 1, 7, 30, 90 for change

• Visual Outcome

  Assessed at all time points;comparison of Day 30 vs Day 90

• Absence of CME

  Assessed on Day -30 to -1 and Day 90 for change

• Need of additional steroids

  Assessed on Days 1, 7, 30, 90 for change

Study Arms (2)

DEXTENZA placed within the upper canaliculus

EXPERIMENTAL

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

Drug: Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA placed within the lower canaliculus

ACTIVE COMPARATOR

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

Drug: Dextenza 0.4Mg Ophthalmic Insert

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA placed within the lower canaliculus; DEXTENZA placed within the upper canaliculus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kerry Assil, MD: lead

Study Sites (1)

Assil Eye Institute

Beverly Hills, California, 90210, United States

RECRUITING

MeSH Terms

Conditions

Cataract; Capsule Opacification; Inflammation; Lens Diseases; Eye Diseases

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Kerry Assil, MD

  Assil Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kellie Burch

CONTACT

310-651-2392; kburch@assileye.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 11, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)