Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%

Part of paid clinical trials in Westbury, New York.

Sponsor
DHS Consulting
Study ID
NCT06539637
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac} — COMBINATION_PRODUCT
    10.16 mg/mL (1% w/v) of phenylephrine {Generic Name: Biorphen} (Adrenergic Receptor Agonist) and 2.88 mg/mL (0.3% w/v) of ketorolac {Generic Name: TORADOL} (Nonsteroidal Anti-inflammatory) - via intracameral delivery
  • Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop — OTHER
    Topical ketorolac tromethamine {TORADOL, Nonsteroidal Anti-inflammatory} (0.5%) administered 4 times daily for the 3 days leading up to surgery. The last drop is to be given at least 2 hours prior to surgery.

Study Details

This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.

Key Dates

Start date
Sep 1, 2023
Status verified
Aug 2024
Primary completion
Nov 30, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: OMIDRIA
    OMIDRIA is a combination product containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Once the 4mL of OMIDRIA is diluted in 500 mL of ophthalmic irrigation solution, the resulting solution is intended to be used as needed during cataract surgery or intraocular lens replacement.
  • Active Comparator: Topical Ketorolac
    Topical ketorolac tromethamine 0.5% is a nonsteroidal anti-inflammatory drug. It is FDA-approved for the treatment of inflammation following cataract surgery and relief of ocular itching due to seasonal allergic conjunctivitis.

Primary Outcome Measure

Concentration of ketorolac in the vitreous humor [ Time Frame: The day of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ophthalmic Consultants of Long IslandWestburyNew York11590
Eric Donnenfeld, MD
516-804-5200
Eric Sigler, MD
516 804 5200

Find similar trials in Westbury, NY

By research site
Ophthalmic Consultants of Long Island· Westbury, NY

Related Studies