Investigate, Following Cataract Surgery With IOL in Conjunction With Intracanalicular Dexamethasone Insert

NCT04465864 | Completed Phase 4 FDA Drug

• 1 other identifier: DEXTENZA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, controlled treatment with an intracanalicular dexamethasone (0.4mg) insert following cataract surgery with intraocular lens implant (IOL) combined with minimally invasive glaucoma surgery (MIGS), specifically iStent, iStent inject or KDB in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHTN)

Conditions

Glaucoma, Primary Open Angle; Cataract

Outcome Measures

Primary Outcomes (1)

• Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery

  Primary: Will receive the insert four days (+/- 1 day) prior to surgery. Each enrolled subject will be required to complete seven scheduled visits over the course of the study period: Baseline, insertion visit, operative visit, Day 1, 7, 30, and a 14 \& 45-day phone call. Absence of cells in anterior chamber at day 7 as measured by: Summed Ocular Inflammation Score (0-4) Absence of cell to be defined as a grade of (0-0.5) Absence of pain at Day 7 (score of 0) as measured by ocular pain assessment numerical grading scale 0-10 Mean change in BCVA from baseline (Day 7,30) Mean change in OCT from baseline (Day 30) Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire Incidence and severity of ocular and systemic AE's (Day 1,7,14,30,45)

  four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.

Secondary Outcomes (1)

• Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.

  insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.

Study Arms (2)

Insertion visit 4 days prior

OTHER

Intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)

Drug: Intracanalicular Dexamethasone, 0.4 mg insert

Surgical 1 visit day 0

OTHER

Intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)

Drug: Intracanalicular Dexamethasone, 0.4 mg insert

Interventions

Intracanalicular Dexamethasone, 0.4 mg insert DRUG

Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery or inserted the day of surgery.

Also known as: MIGS (iStent, iStent inject or KDB) insertion.

Insertion visit 4 days prior; Surgical 1 visit day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Been diagnosed with POAG or OHTN and MIGS (iStent, iStent inject or KDB) has been planned
• Unilateral or 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:

• Patients under the age of 18.
• Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
• Active infectious systemic disease
• Active infectious ocular or extraocular disease
• Unobstructed 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, including Lasik or PRK
• History of ocular inflammation or macular edema
• Patients being treated with \>375mg daily of NSAIDs
• o Patients on doses higher than 375mg of oral NSAIDs will be considered if they discontinue the medication 2 weeks prior to the study start date.
• Patients taking inconsistent varying doses of an NSAID on a daily basis.
• 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

• Wolstan and Goldberg Eye Associates: lead

Study Sites (1)

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract

Interventions

Mutagenesis, Insertional; Drug Implants

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Damien Goldberg, MD

  Wolstan & Goldberg Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery) Group 2: intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: July 10, 2020
• Study Start: February 10, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)