Trials Sponsors Conditions Drugs Pricing

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 EyedropOther

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able to provide informed consent
Undergoing cataract surgery immediately followed by pars plana vitrectomy

Sponsors & Collaborators

DHS Consulting
Otherlead

Study Sites (1)

Ophthalmic Consultants of Long Island

Westbury, New York, 11590, United States

RECRUITING

Eric Donnenfeld, MDCONTACT516-804-5200

Eric Sigler, MDCONTACT516 804 5200

MeSH Terms

Conditions

Cataract

Interventions

PhenylephrineKetorolacOphthalmic Solutions

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesIndomethacinIndoles

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

Actual (reported)

Primary Completion

November 2025

Estimated (date passed)

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%

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

OMIDRIA

Topical Ketorolac

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

OMIDRIA

Topical Ketorolac

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations