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%

NCT06539637 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 00068701
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Concentration of ketorolac in the vitreous humor

  Vitreous samples taken from vitrectomy at the beginning of the procedure for all patients.

  The day of surgery

Study Arms (2)

OMIDRIA

ACTIVE COMPARATOR

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.

Combination Product: OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}

Topical Ketorolac

ACTIVE COMPARATOR

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.

Other: Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop

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

OMIDRIA

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.

Topical Ketorolac

Eligibility Criteria

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

You may qualify if:

• Able to provide informed consent
• Undergoing cataract surgery immediately followed by pars plana vitrectomy
• Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)
• Willing and able to comply with all study procedures
• Male or female, aged ≥ 18 years

You may not qualify if:

• Age \< 18
• Participating in another clinical trial
• Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)
• Previous vitrectomy
• Complications at the time of cataract surgery
• A tear in the posterior capsule

Sponsors & Collaborators

• DHS Consulting: lead

Study Sites (1)

Ophthalmic Consultants of Long Island

Westbury, New York, 11590, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Phenylephrine; Ketorolac; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Eric Donnenfeld, MD

  Ophthalmic Consultants of Long Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Donnenfeld, MD

CONTACT

516 804 5200; ericdonnenfeld@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)