Recruiting
Early Phase 1

Ketorolac with Phenylephrine

Sponsor:

DHS Consulting

Code:

NCT06539637

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

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}

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

Study Details

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

Study ID

NCT06539637

Start date

Sep 1, 2023

Status verified date

Aug, 2024

Completion date

Feb, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Age < 18
2. Participating in another clinical trial
3. Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)
4. Previous vitrectomy
5. Complications at the time of cataract surgery
6. A tear in the posterior capsule

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eric Donnenfeld, MD

516 804 5200ericdonnenfeld@gmail.com

Locations

Ophthalmic Consultants of Long Island

Recruiting

Westbury, New York, United States, 11590

Contacts

Eric Donnenfeld, MD

516-804-5200

Eric Sigler, MD

516 804 5200

More Information

Sponsor

DHS Consulting

Last update posted

Aug 6, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by DHS Consulting on 2024-08-06.